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July 25, 2018  Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com  AbbVie Receives U.S. FDA Approval of ORILISSA™ (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis https://www.prnewswire.com/news-releases/abbvie-receives-us-fda-approval-of-orilissa-elagolix-for-the-management-of-moderate-to-severe-pain-associated-with-endometriosis-300685204.html U.S. FDA Grants Landmark Class II Approval for Clinical Grade Smartphone Testing - Healthy.io’s Dip.io Urinalysis https://www.prnewswire.com/news-releases/a-big-win-for-digital-health-u-s-fda-grants-landmark-class-ii-approval-for-clinical-grade-smartphone-testing-healthy-io-s-dip-io-urinalysis-876104663.html  FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer https://www.prnewswire.com/news-releases/fda-approves-magnetic-device-system-for-guiding-sentinel-lymph-node-biopsies-in-certain-patients-with-breast-cancer-300685949.html I have a couple of new courses on Udemy, an online platform with low cost courses in all kinds of topics. If you type in “Emma Nichols”, you’ll pull up my courses. The latest ones are Cancer Biology 101, How to Read and Interpret a Scientific Paper, and Freelance Medical Writing as a Career Choice. To check those out, just go to Udemy.com (Udemy.com) and type in “Emma Nichols” to pull them up. newfdaapprovals.com Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com            

July 23, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation https://www.prnewswire.com/news-releases/fda-approves-first-targeted-treatment-for-patients-with-relapsed-or-refractory-acute-myeloid-leukemia-who-have-a-certain-genetic-mutation-300684317.html MEDICALgorithmics, Medi-Lynx Receive FDA 510(K) Clearance for PocketECG CRS Mobile Cardiac Rehabilitation System https://www.prnewswire.com/news-releases/medicalgorithmics-medi-lynx-receive-fda-510k-clearance-for-pocketecg-crs-mobile-cardiac-rehabilitation-system-300684623.html  Allergan Receives FDA Fast Track Designation for AGN-241751 for the Treatment of Major Depressive Disorder (MDD) https://www.prnewswire.com/news-releases/allergan-receives-fda-fast-track-designation-for-agn-241751-for-the-treatment-of-major-depressive-disorder-mdd-300684622.html IDT's Customer Senseonics Receives FDA Approval for its Implantable Glucose Sensor https://www.prnewswire.com/news-releases/idts-customer-senseonics-receives-fda-approval-for-its-implantable-glucose-sensor-300684424.html Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency’s continued commitment to postmarket review of Essure and keeping women informed https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614123.htm New courses on Udemy.com. If you type in “Emma Nichols”, you’ll pull up my courses. The latest ones are Cancer Biology 101, How to Read and Interpret a Scientific Paper, and Freelance Medical Writing as a Career Choice. To check those out, just go to Udemy.com (Udemy.com) and type in “Emma Nichols” to pull them up.

July 19, 2018  Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:45 Janssen Announces U.S. FDA Approval of SYMTUZA™ (D/C/F/TAF), the First and Only Complete Darunavir-Based Single-Tablet Regimen for the Treatment of HIV-1 Infection https://www.prnewswire.com/news-releases/janssen-announces-us-fda-approval-of-symtuza-dcftaf-the-first-and-only-complete-darunavir-based-single-tablet-regimen-for-the-treatment-of-hiv-1-infection-300682550.html  3:00 PainReform Gets FDA Approval for Phase III Post-Operative Pain Relief Study https://www.prnewswire.com/news-releases/painreform-gets-fda-approval-for-phase-iii-post-operative-pain-relief-study-300682836.html 4:08 Asceneuron's Tau Modifier ASN120290 Receives Orphan Drug Designation for Progressive Supranuclear Palsy From the FDA https://www.prnewswire.com/news-releases/asceneuron-s-tau-modifier-asn120290-receives-orphan-drug-designation-for-progressive-supranuclear-palsy-from-the-fda-859244062.html 6:20 MaxCyte Receives US FDA Investigational New Drug Clearance for First Clinical Program https://www.prnewswire.com/news-releases/maxcyte-receives-us-fda-investigational-new-drug-clearance-for-first-clinical-program-300681147.html 8:17 Camurus Announces PDUFA Date for CAM2038 for the Treatment of Opioid use Disorder https://www.prnewswire.com/news-releases/camurus-announces-pdufa-date-for-cam2038-for-the-treatment-of-opioid-use-disorder-300681160.html 9:33 FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613801.htm 12:16 Statement from FDA Commissioner Scott Gottlieb, M.D. on new efforts to empower consumers by advancing access to nonprescription drugs https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613692.htm Just to let you know, I have a couple of new courses on Udemy. If you type in “Emma Nichols”, you’ll pull up my courses. The latest ones are Cancer Biology 101, How to Read and Interpret a Scientific Paper, and Freelance Medical Writing as a Career Choice. To check those out, just go to Udemy.com (Udemy.com) and type in “Emma Nichols” to pull them up.   Music credit: freemusicarchive.org/music/MindsEye/Yellow_Taxi/

July 16, 2018  Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:38 FDA approves the first drug with an indication for treatment of smallpox https://www.prnewswire.com/news-releases/fda-approves-the-first-drug-with-an-indication-for-treatment-of-smallpox-300680846.html 2:27 FDA Approves XTANDI® (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC) https://www.prnewswire.com/news-releases/us-fda-approves-xtandi-enzalutamide-for-the-treatment-of-men-with-non-metastatic-castration-resistant-prostate-cancer-crpc-300680822.html 3:47 Roche PCT assay cleared for expanded use - Important tool in antibiotic resistance crisis https://www.prnewswire.com/news-releases/roche-pct-assay-cleared-for-expanded-use--important-tool-in-antibiotic-resistance-crisis-300680818.html  5:47 Amgen And UCB Resubmit Biologics License Application (BLA) For EVENITY™ (romosozumab) To The US FDA https://www.prnewswire.com/news-releases/amgen-and-ucb-resubmit-biologics-license-application-bla-for-evenity-romosozumab-to-the-us-fda-300680499.html  I have a couple of new courses on Udemy.com. Udemy is an online platform with low cost courses in all kinds of topics. If you type in “Emma Nichols”, you’ll pull up my courses. The latest ones are Cancer Biology 101, How to Read and Interpret a Scientific Paper, and Freelance Medical Writing as a Career Choice. To check those out, just go to Udemy.com (Udemy.com) and type in “Emma Nichols” to pull them up. Music credit: freemusicarchive.org/music/MindsEye/Yellow_Taxi/

  July 12, 2018  Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.co 0:35 Recursion Receives FDA Clearance of Investigational New Drug Application to Initiate First Clinical Trial of REC-994 in Cerebral Cavernous Malformation https://www.prnewswire.com/news-releases/recursion-receives-fda-clearance-of-investigational-new-drug-application-to-initiate-first-clinical-trial-of-rec-994-in-cerebral-cavernous-malformation-300678055.html 2:25 RedDress Receives FDA 510(k) Clearance for RD1 System. Innovative Device for Wound Management. https://www.prnewswire.com/news-releases/reddress-receives-fda-510k-clearance-for-rd1-system-300677736.html  3:27 Oculocare's Alleye® Receives FDA 510(k) clearance for monitoring Eyesight in AMD https://www.prnewswire.com/news-releases/oculocare-s-alleye-receives-fda-510-k-clearance-for-monitoring-eyesight-in-amd-810529944.html  5:05 Bausch + Lomb Announces U.S. FDA Filing Acceptance For Loteprednol Etabonate Ophthalmic Gel, 0.38% https://www.prnewswire.com/news-releases/bausch--lomb-announces-us-fda-filing-acceptance-for-loteprednol-etabonate-ophthalmic-gel-0-38-300677545.html  6:01 OBI Pharma Granted FDA Orphan Drug Designation for OBI-3424 for the Treatment of Hepatocellular Carcinoma (HCC) https://www.prnewswire.com/news-releases/obi-pharma-granted-fda-orphan-drug-designation-for-obi-3424-for-the-treatment-of-hepatocellular-carcinoma-hcc-300677533.html  8:11 FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reaction https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm612995.htm  10:20 Statement from FDA Commissioner Scott Gottlieb, M.D. on agency’s efforts to advance development of gene therapies https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613026.htm I have a couple of new courses on Udemy.com, which is an online platform with low cost courses in all kinds of topics. If you type in “Emma Nichols”, you’ll pull up my courses. The latest ones are Cancer Biology 101, How to Read and Interpret a Scientific Paper, and Freelance Medical Writing as a Career Choice. To check those out, just go to Udemy.com (Udemy.com) and type in “Emma Nichols” to pull them up.

July 9, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:49  Lipogems' Receives FDA Clearance For Microfragmented Adipose Tissue System Utilizing Body's Own Fat To Support Tissue Repair In Orthopaedic And Arthroscopic Surgeries https://www.prnewswire.com/news-releases/fda-clears-the-way-lipogems-receives-fda-clearance-for-microfragmented-adipose-tissue-system-utilizing-bodys-own-fat-to-support-tissue-repair-in-orthopaedic-and-arthroscopic-surgeries-300676836.html  2:28 Compugen Welcomes FDA Clearance of Bayer's IND Application for BAY 1905254 https://www.prnewswire.com/news-releases/compugen-welcomes-fda-clearance-of-bayers-ind-application-for-bay-1905254-300675233.html  3:54 FDA Approves ARISTADA INITIO™ for the initiation of ARISTADA® for schizophrenia https://www.prnewswire.com/news-releases/fda-approves-aristada-initio-for-the-initiation-of-aristada-for-schizophrenia-300675138.html 5:38 Compugen Announces FDA Clearance of IND Application for COM701, a First-in-class Immuno-Oncology Therapeutic Antibody https://www.prnewswire.com/news-releases/compugen-announces-fda-clearance-of-ind-application-for-com701-a-first-in-class-immuno-oncology-therapeutic-antibody-884797663.html  7:28 ReCor Medical Announces FDA Approval Of IDE For Pivotal Study Of Paradise® Ultrasound Denervation System For Treatment Of Hypertension https://www.prnewswire.com/news-releases/recor-medical-announces-fda-approval-of-ide-for-pivotal-study-of-paradise-ultrasound-denervation-system-for-treatment-of-hypertension-300675184.html  Brought to you by Nascent Medical. For assistance with medical writing, please email info@nascentmc.com.  Music credit: freemusicarchive.org/music/MindsEye/Yellow_Taxi/

July 2, 2018  Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com  0:44 Array BioPharma Announces FDA Approval of BRAFTOVI™ (encorafenib) in Combination with MEKTOVI® (binimetinib) https://www.prnewswire.com/news-releases/array-biopharma-announces-fda-approval-of-braftovi-encorafenib-in-combination-with-mektovi-binimetinib-300673447.html  3:03 sNDA for Xyrem® (sodium oxybate) to Treat Cataplexy and Excessive Daytime Sleepiness in Pediatric Narcolepsy Patients https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-fda-acceptance-of-supplemental-new-drug-application-for-xyrem-sodium-oxybate-to-treat-cataplexy-and-excessive-daytime-sleepiness-in-pediatric-narcolepsy-patients-300673522.html  4:22 Renovis Surgical receives FDA clearance for Tesera Trabecular Technology™ Hyperlordotic ALIF interbody spinal fusion system https://www.prnewswire.com/news-releases/renovis-surgical-receives-fda-clearance-for-tesera-trabecular-technology-hyperlordotic-alif-interbody-spinal-fusion-system-300673873.html  5:08 FDA approves novel device for treating breathing difficulty from severe emphysema https://www.prnewswire.com/news-releases/fda-approves-novel-device-for-treating-breathing-difficulty-from-severe-emphysema-300674744.html https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm612271.htm  7:10 FDA approves Dermira's wipe for excessive armpit sweating https://www.prnewswire.com/news-releases/carpe-founders-and-advisors-celebrate-dermira-product-announcement-300674880.html https://www.cnbc.com/2018/06/29/fda-approves-dermiras-wipe-for-excessive-armpit-sweating.html  8:26 After nearly 3 years, FDA lifts hold on Aptose cancer drug https://www.fiercebiotech.com/after-nearly-3-years-fda-lifts-hold-aptose-cancer-drug  Brought to you by Nascent Medical. For assistance with medical writing, please email info@nascentmc.com. Music credit: freemusicarchive.org/music/MindsEye/Yellow_Taxi

June 28, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0.33 FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611046.htm https://www.prnewswire.com/news-releases/first-prescription-formulation-of-cannabidiol-cbd-approved-for-lennox-gastaut-syndrome-300672005.html  2:43 Beckman Coulter Diagnostics Receives U.S. FDA 510(k) Clearance for High- sensitivity Access hsTnI Assay https://www.prnewswire.com/news-releases/beckman-coulter-diagnostics-receives-us-fda-510k-clearance-for-high--sensitivity-access-hstni-assay-300673012.html 5:20 FDA Authorizes FRESCA Medical To Market New Positive Airway Pressure Delivery System To Treat Sleep Apnea https://www.prnewswire.com/news-releases/fda-authorizes-fresca-medical-to-market-new-positive-airway-pressure-delivery-system-to-treat-sleep-apnea-300671067.html  6:39 Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to advance health through improvements in nutrition under the agency’s Nutrition Innovation Strategy https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611784.htm Brought to you by Nascent Medical. For assistance with medical writing, please email info@nascentmc.com. Music credit: freemusicarchive.org/music/MindsEye/Yellow_Taxi/

June 25, 2018  Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com  0:44 FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients https://www.prnewswire.com/news-releases/fda-permits-marketing-of-first-catheter-based-systems-used-to-create-vascular-access-for-hemodialysis-patients-300670882.html  3:06 Processa Pharmaceuticals Receives Orphan Designation Status For PCS499 In Necrobiosis Lipoidica From The Food And Drug Administration (FDA) https://www.prnewswire.com/news-releases/processa-pharmaceuticals-receives-orphan-designation-status-for-pcs499-in-necrobiosis-lipoidica-from-the-food-and-drug-administration-fda-300670592.html  4:05 FDA approves automated insulin delivery and monitoring system for use in younger pediatric patients https://www.prnewswire.com/news-releases/fda-approves-automated-insulin-delivery-and-monitoring-system-for-use-in-younger-pediatric-patients-300670538.html  5:36 FDA approves first continuous glucose monitoring system with a fully implantable glucose sensor and compatible mobile app for adults with diabetes https://www.prnewswire.com/news-releases/fda-approves-first-continuous-glucose-monitoring-system-with-a-fully-implantable-glucose-sensor-and-compatible-mobile-app-for-adults-with-diabetes-300670465.html Brought to you by Nascent Medical. For assistance with medical writing, please email info@nascentmc.com. Music credit: freemusicarchive.org/music/MindsEye/Yellow_Taxi/ 

June 21, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com  0:47 FDA Grants QIDP Designation to Acurx's Lead Antibiotic Product Candidate, ACX-362E for Clostridium Difficile Infection https://www.prnewswire.com/news-releases/fda-grants-qidp-designation-to-acurxs-lead-antibiotic-product-candidate-acx-362e-for-clostridium-difficile-infection-300669455.html 2:14 Novartis receives FDA approval for inclusion of new evidence that Cosentyx® inhibits progression of joint structural damage in psoriatic arthritis https://www.prnewswire.com/news-releases/novartis-receives-fda-approval-for-inclusion-of-new-evidence-that-cosentyx-inhibits-progression-of-joint-structural-damage-in-psoriatic-arthritis-300668938.html 3:22 Grifols Expands its NAT Solutions Portfolio with New FDA Approvals for Two Assays https://www.prnewswire.com/news-releases/grifols-expands-its-nat-solutions-portfolio-with-new-fda-approvals-for-two-assays-300668493.html 4:30 DreaMed Diabetes Granted FDA Authorization to Market Advisor Pro, Offering Personalized Optimization of Insulin Pump Therapy https://www.prnewswire.com/news-releases/dreamed-diabetes-granted-fda-authorization-to-market-advisor-pro-offering-personalized-optimization-of-insulin-pump-therapy-300667617.html 5:56 FDA responds to ongoing drug shortages for critical products https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611215.htm https://www.fiercepharma.com/manufacturing/fda-says-drug-shortages-again-rise-after-5-years-improvements 8:03 New FDA guidance to help manufacturers implement protections against potential attacks on the U.S. food supply https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611177.htm http://www.cidrap.umn.edu/news-perspective/2018/06/fda-releases-new-guidance-food-defense Please check out my weekly podcast AI in Medicine. Podcast website is aimedicinenews.com  

June 18, 2018  Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com  0:45 FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatment for opioid dependence https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610807.htm https://www.prnewswire.com/news-releases/dr-reddys-laboratories-announces-usfda-final-approval-and-launch-of-buprenorphine-and-naloxone-sublingual-film-in-the-us-market-300667109.html  2:34 BlueWind Medical Receives FDA Approval for Pivotal Trial Design of RENOVA iStim™ Implantable Tibial Nerve Neuromodulator for Overactive Bladder https://www.prnewswire.com/news-releases/bluewind-medical-receives-fda-approval-for-pivotal-trial-design-of-renova-istim-implantable-tibial-nerve-neuromodulator-for-overactive-bladder-685557941.html  4:02 Statement from FDA on emerging food innovation, “cultured” food products https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610869.htm https://qz.com/1306996/the-fda-says-it-wants-to-regulate-clean-meat-products-in-the-us/  7:00 Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to better equip consumers with nutritional information about dietary fiber in their food https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610641.htm Brought to you by Nascent Medical. For assistance with medical writing, please email info@nascentmc.com.  Music credit: freemusicarchive.org/music/MindsEye/Yellow_Taxi/

June 14, 2018Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:48 Samus Therapeutics Announces PU-H71 Granted Orphan Drug Designation and First Patient Dosed in Phase 1b Study in Myelofibrosis https://www.prnewswire.com/news-releases/samus-therapeutics-announces-pu-h71-granted-orphan-drug-designation-and-first-patient-dosed-in-phase-1b-study-in-myelofibrosis-300665566.html  3:34 U.S. FDA Approves Moxidectin For The Treatment Of River Blindness https://www.prnewswire.com/news-releases/us-fda-approves-moxidectin-for-the-treatment-of-river-blindness-300666114.html 6:38 REGENXBIO Receives FDA Fast Track Designation for RGX-111 Gene Therapy for the Treatment of Mucopolysaccharidosis Type I https://www.prnewswire.com/news-releases/regenxbio-receives-fda-fast-track-designation-for-rgx-111-gene-therapy-for-the-treatment-of-mucopolysaccharidosis-type-i-300665253.html 9:17 U.S. Food and Drug Administration Clears Wearable Device to Treat Opioid Addiction https://www.prnewswire.com/news-releases/us-food-and-drug-administration-clears-wearable-device-to-treat-opioid-addiction-300664443.html 11:07 Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610503.htm http://www.cidrap.umn.edu/news-perspective/2018/06/fda-head-looks-boost-antibiotic-development Please check out my weekly podcast AI in Medicine. In this episode, I talk to Dr. Suvas Vajracharya, CEO and Founder, Lightning Bolt Solutions, Inc. Using an AI-based platform, Lightning Bolt manages over 3 million shift hours each month, scheduling 20,000 clinicians at 350 healthcare organizations. Podcast website is aimedicinenews.com. Music credit: freemusicarchive.org/music/MindsEye/Yellow_Taxi/

June 11, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:58 AbbVie Announces U.S. FDA Approval of VENCLEXTA® (venetoclax tablets) in Combination with Rituximab as a Fixed Duration Treatment for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Patients Who Have Received One Prior Therapy https://www.prnewswire.com/news-releases/abbvie-announces-us-fda-approval-of-venclexta-venetoclax-tablets-in-combination-with-rituximab-as-a-fixed-duration-treatment-for-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma-patients-who-have-received-one-prior--300662514.html  3:10 FDA Clearance of Investigational New Drug Application for CK0801 for Bone Marrow Failure Syndromes https://www.prnewswire.com/news-releases/cellenkos-inc-announces-fda-clearance-of-investigational-new-drug-application-for-ck0801-for-bone-marrow-failure-syndromes-300663808.html 5:17 Centinel Spine Announces 510(k) Clearance of FLX™ Platform of 3D Printed All-Titanium Interbodies https://www.prnewswire.com/news-releases/centinel-spine-announces-510k-clearance-of-flx-platform-of-3d-printed-all-titanium-interbodies-300661595.html 5:59 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610206.htm https://www.natlawreview.com/article/fda-and-cdc-release-results-2017-national-youth-tobacco-survey Brought to you by Nascent Medical. For assistance with medical writing, please email info@nascentmc.com. Music credit: freemusicarchive.org/music/MindsEye/Yellow_Taxi/

June 7, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:50 FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609805.htm https://www.prnewswire.com/news-releases/us-fda-approves-mylan-and-biocons-fulphila-pegfilgrastim-jmdb-the-first-biosimilar-to-neulasta-300659410.html 2:18 FDA approves Leukine® (sargramostim) for the treatment of acute radiation syndrome https://www.prnewswire.com/news-releases/partner-therapeutics-ptx-announces-us-fda-approval-of-leukine-sargramostim-for-the-treatment-of-acute-radiation-syndrome-300660612.html 4:23 Roche gets priority review from FDA for Hemlibra https://www.reuters.com/article/us-roche-hemlibra/roche-gets-priority-review-from-fda-for-hemlibra-idUSKCN1J10HF https://www.roche.com/media/releases/med-cor-2018-06-05.htm 7:03 FDA's Office of New Drugs reorganization https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609647.htm http://www.pharmexec.com/fda-launches-overhaul-new-drug-review-program Brought to you by Nascent Medical. For assistance with medical writing, please email info@nascentmc.com. Music credit: freemusicarchive.org/music/MindsEye/Yellow_Taxi/  

June 1, 2018 0:54 Statement from FDA Commissioner Scott Gottlieb, M.D., on the signing of the Right to Try Act https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609258.htm 2:38 FDA approves new treatment for moderately to severely active ulcerative colitis https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609225.htm https://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_u_s_fda_approves_xeljanz_tofacitinib_for_the_treatment_of_moderately_to_severely_active_ulcerative_colitis 4:50 Baricitinib 2-mg tablets for the treatment of adults with moderately-to-severely active rheumatoid arthritis https://www.prnewswire.com/news-releases/fda-approves-olumiant-baricitinib-2-mg-tablets-for-the-treatment-of-adults-with-moderately-to-severely-active-rheumatoid-arthritis-300658215.html 6:12 FDA approves first artificial iris https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609291.htm 8:10 510(k) clearance for AURA™ ICP Monitoring System https://www.prnewswire.com/news-releases/branchpoint-technologies-announces-fda-510k-for-its-aura-intracranial-pressure-monitoring-system-300657454.html 9:40 FDA Approval For Neuro Stent Device https://www.prnewswire.com/news-releases/microvention-announces-fda-approval-for-neuro-stent-device-300657235.html 11:05 NDA for NKTR-181, a First-in-Class Investigational Opioid to Treat Chronic Low Back Pain in Adult Patients New to Opioid Therapy https://www.prnewswire.com/news-releases/nektar-therapeutics-announces-submission-of-a-new-drug-application-to-the-us-fda-for-nktr-181-a-first-in-class-investigational-opioid-to-treat-chronic-low-back-pain-in-adult-patients-new-to-opioid-therapy-300657081.html  12:30 Priority Review for antiepileptic drug FYCOMPA® (perampanel) CIII for pediatric patients https://www.prnewswire.com/news-releases/eisai-receives-fda-priority-review-designation-for-fycompa-perampanel-ciii-pediatric-indications-supplemental-new-drug-application-snda-300656500.html 13:50 FDA Approval of TX-004HR: IMVEXXY™ (estradiol vaginal inserts), the Lowest Dose Vaginal Estrogen Product Approved for the Treatment of Moderate to Severe Dyspareunia, a Symptom of VVA, due to Menopause https://www.prnewswire.com/news-releases/therapeuticsmd-announces-fda-approval-of-tx-004hr-imvexxy-estradiol-vaginal-inserts-the-lowest-dose-vaginal-estrogen-product-approved-for-the-treatment-of-moderate-to-severe-dyspareunia-a-symptom-of-vva-due-to-menopause-300656468.html 14:50 clearance of IND application on CAR-T immuno-cell therapy for the Treatment of Multiple Myeloma https://www.prnewswire.com/news-releases/legend-announces-fda-clearance-of-ind-application-on-car-t-immuno-cell-therapy-for-the-treatment-of-multiple-myeloma-300656364.html 16:30 As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609188.htm Music credit: freemusicarchive.org/music/MindsEye/Yellow_Taxi/    

May 30, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:01 Pfizer’s XALKORI® (crizotinib) receives FDA breakthrough therapy designation in two new indications https://investors.pfizer.com/investor-news/press-release-details/2018/Pfizers-XALKORI-crizotinib-Receives-FDA-Breakthrough-Therapy-Designation-in-Two-New-Indications/default.aspx 3:14 UCB announces the approval of CIMZIA® (certolizumab pegol) for moderate-to-severe plaque psoriasis https://www.prnewswire.com/news-releases/ucb-announces-the-approval-of-cimzia-certolizumab-pegol-for-moderate-to-severe-plaque-psoriasis-representing-an-important-new-option-for-patients-in-the-us-300655645.html 5:29 Zeto announces first dry electrode, wireless EEG headset approved by FDA for clinical use https://www.prnewswire.com/news-releases/zeto-announces-first-dry-electrode-wireless-eeg-headset-approved-by-fda-for-clinical-use-300655286.html 7:40 FDA accepts larotrectinib new drug application and grants priority review solid tumors harboring https://www.prnewswire.com/news-releases/fda-accepts-larotrectinib-new-drug-application-and-grants-priority-review-300655627.html 10:17 TrioxBio Announces Fast Track Designation Granted by U.S. FDA to Raviten® https://www.prnewswire.com/news-releases/trioxbio-announces-fast-track-designation-granted-by-us-fda-to-raviten-for-the-treatment-of-intradialytic-hypotension-683935721.html  Please check out my weekly podcast AI in Medicine. In this week’s episode I talk to Chris Mansi who is CEO and co-founder of Viz.ai. Viz technology helps detect LVO and uses an AI algorithm to classify patients with stroke who need immediate treatment. Check it out at aimedicinenews.com Music credit: freemusicarchive.org/music/MindsEye/Yellow_Taxi/

May 25, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:49 FDA approves a new treatment for PKU, a rare and serious genetic disease https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608835.htm 3:11 FDA permits marketing of artificial intelligence algorithm for aiding providers in detecting wrist fractures https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608833.htm  6:01 FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608325.htm  Please check out my weekly podcast AI in Medicine. In this week’s episode I talk to Chris Mansi, MD, with Viz.ai. His company has developed a software technology using AI for early detection of Large Vessel Occlusion, therefore allowing earlier treatment of stroke. Podcast website is aimedicinenews.com Music credit: freemusicarchive.org/music/MindsEye/Yellow_Taxi/

Wednesday, May 23, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:45 FDA to review Zynquista™ (sotagliflozin) as potential treatment for type 1 diabetes https://www.prnewswire.com/news-releases/fda-to-review-zynquista-sotagliflozin-as-potential-treatment-for-type-1-diabetes-300652146.html 2:10 Providence Medical Technology announces FDA 510(k) clearance for DTRAX® Spinal System https://www.prnewswire.com/news-releases/providence-medical-technology-announces-fda-510k-clearance-for-dtrax-spinal-system-300652309.html  3:38 FDA approves Prolia® (denosumab) for glucocorticoid-induced osteoporosis https://www.prnewswire.com/news-releases/fda-approves-prolia-denosumab-for-glucocorticoid-induced-osteoporosis-300652126.html  5:20 FDA approves Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease https://www.prnewswire.com/news-releases/fda-approves-new-drug-for-patients-with-chronic-liver-disease-who-have-low-blood-platelets-and-are-undergoing-a-medical-procedure-300651897.html https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608320.htm 7:20 Cerenovus receives FDA clearance for next generation stent retriever device used to treat ischemic stroke https://www.prnewswire.com/news-releases/cerenovus-receives-fda-clearance-for-next-generation-stent-retriever-device-used-to-treat-ischemic-stroke-300651419.html  9:44 FDA approves Restylane® Lyft dermal filler for hands https://www.prnewswire.com/news-releases/nestle-skin-health-announces-the-fda-approval-of-restylane-lyft-for-hands-the-first-and-only-hyaluronic-acid-ha-dermal-filler-for-use-in-the-back-of-hands-300651736.html  11:04 New FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608499.htm  Brought to you by Nascent Medical. For assistance with medical writing, please email info@nascentmc.com.  Music credit: freemusicarchive.org/music/MindsEye/Yellow_Taxi/

May 18, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com  1:03 FDA approves novel preventive treatment for migraine https://www.prnewswire.com/news-releases/fda-approves-novel-preventive-treatment-for-migraine-300650782.html 2:44 FDA approves LUCEMYRA™ (lofexidine) after priority review for the management of opioid withdrawal symptoms https://www.prnewswire.com/news-releases/fda-approves-us-worldmeds-lucemyra-lofexidine-after-priority-review-for-the-management-of-opioid-withdrawal-symptoms-300649939.html https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607884.htm 4:55 FDA clears patient specific 3D printed bone segments for the global extremities market https://www.prnewswire.com/news-releases/additive-orthopaedics-announces-fda-clearance-of-their-patient-specific-3d-printed-bone-segments-for-the-global-extremities-market-300649830.html 5:45 Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to shine light on situations where drug makers may be pursuing gaming tactics to delay generic competition https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607930.htm Brought to you by Nascent Medical. For assistance with medical writing, please email info@nascentmc.com. Udemy course Freelance Medical Writing as a Career Choice. This is a 35-minute course giving an overview of what qualifications are needed, what skills and attributes are helpful and how much money you can make. https://www.udemy.com/freelance-medical-writing-career/?couponCode=MEDICALWRITING Music credit: freemusicarchive.org/music/MindsEye/Yellow_Taxi/

May 16, 2018  Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com  1:25 Castle Creek Pharmaceuticals Receives FDA Rare Pediatric Disease Designation for Diacerein 1% Ointment for Epidermolysis Bullosa https://www.prnewswire.com/news-releases/castle-creek-pharmaceuticals-receives-fda-rare-pediatric-disease-designation-for-diacerein-1-ointment-for-epidermolysis-bullosa-300649448.html 3:21 FDA approves first epoetin alfa biosimilar for the treatment of anemia https://www.prnewswire.com/news-releases/fda-approves-first-epoetin-alfa-biosimilar-for-the-treatment-of-anemia-300648734.html https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607703.htm 4:21 Medic Vision: new FDA-cleared MRI image enhancement technology enables reduction of scan time and increased resolution https://www.prnewswire.com/news-releases/medic-vision-new-fda-cleared-mri-image-enhancement-technology-enables-reduction-of-scan-time-and-increased-resolution-682660651.html 5:26 Novartis announces FDA approval of Gilenya® as the first disease-modifying therapy for pediatric relapsing multiple sclerosis https://www.prnewswire.com/news-releases/novartis-announces-fda-approval-of-gilenya-as-the-first-disease-modifying-therapy-for-pediatric-relapsing-multiple-sclerosis-300647266.html https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607501.htm  Music credit: freemusicarchive.org/music/MindsEye/Yellow_Taxi/