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New FDA Approvals

Emma Hitt Nichols, PhD

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The New FDA Approvals podcast is a weekly podcast that aims to help clinicians, medical writers, and pharmaceutical industry executives stay up to date on the latest FDA approvals. Join Dr. Emma Hitt Nichols each Monday morning for an update on the previous week’s FDA activities.
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FDA Drug Safety Podcasts

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

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FDA Drug Safety Podcasts, produced by FDA's Center for Drug Evaluation and Research, provide emerging safety information about drugs in conjunction with the release of Drug Safety Communications. For more information, please visit: www.fda.gov/drugsafetypodcasts
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Saudi FDA

Saudi FDA

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الهيئة العامة للغذاء والدواء - بالأهم نهتم Saudi Food & Drug Authority Unified Call Center 19999 مركز الاتصال الموحد
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I Wish I Knew What I Know Now: Conversations With AGG on FDA Issues is a legal podcast hosted by Arnall Golden Gregory LLP. In this podcast series, different members of our Food & Drug practice and colleagues in other related life science teams will discuss issues and challenges they have encountered when assisting clients on business and legal matters.
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Nascentmc.com for medical writing assistance for your company. Visit nascentmc.com/podcast for full show notes Visit learnAMAstyle.com for free downloads regarding editing and the AMA Manual of Style tip sheet. Nexletol and Nexlizet for LDL Lowering and CV Risk: The FDA approved bempedoic acid (Nexletol) and its combination with ezetimibe (Nexlizet…
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Please visit nascentmc.com/podcast for all the details. Go to learnAMAstyle.com for lots of freebies on AMA Style and the use of AI in medical writing and editing Here is information on the latest US FDA approvals, the week of March 11 – March 15, 2024 Liso-cel for CLL/SLL - The FDA approved lisocabtagene maraleucel (liso-cel; Breyanzi) for adult p…
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Here is information on the latest US FDA approvals, the week of March 4 – March 8, 2024 · ChatGPT4 in medical writing and editing—visit learnAMAstyle.com · Nascentmc.com for medical writing assistance for your company. Visit nascentmc.com/podcast for full show notes - **OTC Glucose Monitor**: The FDA has approved the Dexcom Stelo Glucose Biosensor …
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Visit nascentmc.com/podcast for full show notes Visit learnamastyle.com for the free course on ChatGPT4 for medical writers and editors. - The FDA has approved amivantamab (Rybrevant) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSC…
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· ChatGPT4 in medical writing and editing FREE COURSE at learnAMAstyle.com · Nascentmc.com for medical writing assistance for your company. Visit nascentmc.com/podcast for full show notes Enmetazobactam for cUTI: The FDA approved enmetazobactam (Exblifep) for complicated urinary tract infections (cUTIs) in adults, offering a new weapon against anti…
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` Free course on ChatGPT4 in medical writing and editing at learnAMAstyle.com · Nascentmc.com for medical writing assistance for your company. Visit nascentmc.com/podcast for full show notes Lifileucel for Melanoma: Lifileucel (Amtagvi) has received accelerated FDA approval for unresectable metastatic melanoma in adults previously treated with spec…
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Visit nascentmc.com/podcast for full show notes [free course] ChatGPT4 in medical writing and editing at learnAMAstyle.com Nascentmc.com for medical writing assistance for your CME or Medical Communications company. Eplontersen for ATTR-CM Eplontersen received FDA Fast Track designation for treating transthyretin-mediated amyloid cardiomyopathy (AT…
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Listen to FDA Drug Safety Podcast titled, FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab).
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ChatGPT4 in medical writing and editing at learnAMAstyle.com Nascentmc.com for medical writing assistance for your company. Visit nascentmc.com/podcast for full show notes Tricuspid Valve Replacement System for Tricuspid Regurgitation The FDA approved the Evoque tricuspid valve replacement system, a first in the U.S. for a transcatheter tricuspid d…
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Free course ChatGPT4 in medical writing and editing at learnAMAstyle.com · Nascentmc.com for medical writing assistance for your company.Visit nascentmc.com/podcast for full show notes Boxed Warning for CAR-T Cell Therapy: The FDA mandates a boxed warning on all CAR T-cell therapies due to increased secondary cancer risks, affecting six named treat…
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For the free course "ChatGPT4 for Medical Writers and Editors," go to learnAMAstyle.com Visit Nascentmc.com/podcast for detailed show notes and links. Erdafitinib for Urothelial Carcinoma: The FDA has fully approved erdafitinib (Balversa) for advanced or metastatic urothelial carcinoma with FGFR3 genetic alterations in adults. This follows its init…
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Visit nascentmc.com to get medical writing assistance for your company. Visit learnAMAstyle.com for free downloads about medical editing and writing in the AI era. See full write up and supporting links for this episode at nascentmc.com/podcast. Summary: § FDA has approved berdazimer topical gel, 10.3% (Zelsuvmi), as the first novel drug for mollus…
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Use Your Scientific or Medical Background in Medical Editing & Factchecking so you can supplement your income while working from anywhere on your own schedule. Visit learnAMAstyle.com for a free step-by-step checklist. Get immediate medical writing assistance from experienced, excellent, native-English speaking MD- and PhD-medical writers. Nascentm…
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Summary: Visit learnAMAstyle.com for the downloadable AMA Style cheat sheet Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's ep…
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For the AMA Style cheat sheet learnamastyle.com See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights: Test for Risk of Opioid Addiction:The FDA has approved AvertD by SOLVD Health, a test for assessing opioid addiction risk in individuals over 18, using genetic variants to evaluate addiction risk before prescr…
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Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcastHere are the highlights: Belzutifan (Welireg) …
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Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights: 1. Iptacopan (Fabhal…
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Listen to an audio podcast of the November 28, 2023, FDA Drug Safety Communication, FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan).
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Summary: Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights: Nirogacesta…
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Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights: · Capivasertib (Truq…
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Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights: The FDA has approved…
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Summary: Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights: Pembrolizum…
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Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights: · Loqtorzi (toripali…
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Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights: BIMZELX (bimekizumab…
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Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights: Velsipity (Etrasimod…
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Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights: Novavax COVID Vaccin…
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Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights: Ryzumvi (Phentolamin…
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In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from September 18, 2023 – September 22, 2023. Please check back every Monday morning so that you can stay up to date. Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Ass…
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In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from September 11, 2023 – September 15, 2023. Please check back every Monday morning so that you can stay up to date. See more details summaries and links to prescribing information at nascentmc.com/podcast Here are the highlights: • Ojjaara …
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In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from August 28, 2023 – September 8, 2023. Please check back every Monday morning so that you can stay up to date. Here is information on the latest US FDA approvals, the week of August 28 – September 8, 2023. Check out our free downloads at n…
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Summary: In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from August 21, 2023 – August 25, 2023. Please check back every Monday morning so that you can stay up to date. See more details summaries and links to prescribing information at nascentmc.com/podcast Here are the highlights: FDA App…
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Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episodes at nascentmc.com/podcast · Elrexfio (elranatamab-bcmm) has received a…
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Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episodes at nascentmc.com/podcast In this week's New FDA Approval's podcast ep…
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Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episodes at nascentmc.com/podcast In this week's New FDA Approval's podcast ep…
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Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episodes at nascentmc.com/podcast Here is information on the latest US FDA app…
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In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from July 17, 2023 – July 21, 2023. Please check back every Monday morning so that you can stay up to date. Here are the highlights: Vanflyta® for FLT3-ITD+ AML The FDA has approved Vanflyta (quizartinib), developed by Daiichi Sankyo, for tre…
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In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from July 10, 2023 – July 14, 2023. Please check back every Monday morning so that you can stay up to date. Get our free download! Implementing AMA Style – 8 Things to Get Right Here are the highlights of this week's episode: Opill® is the fi…
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Get our free download! Implementing AMA Style – 8 Things to Get Right Here are the highlights of this week's episode: · The FDA granted traditional approval to Leqembi, an Alzheimer's treatment manufactured by Eisai and Biogen. The approval, based on phase 3 data demonstrating reduced cognitive decline in early Alzheimer's patients, makes Leqembi t…
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Get our free download! Implementing AMA Style – 8 Things to Get Right In this episode, we discuss the latest FDA approvals from June 26 – June 30, 2023. Lantidra (donislecel-jujn) has been FDA approved for the treatment of type 1 diabetes. Lantidra is an allogeneic pancreatic islet cellular therapy derived from deceased donor pancreatic cells. Ngen…
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Get our free download! Implementing AMA Style – 8 Things to Get Right In this episode, we discuss the latest FDA approvals from June 19 – June 23, 2023. Here are the key highlights: · The FDA has given approval to Pfizer's Talzenna and Xtandi for treating metastatic castration-resistant prostate cancer in adults with certain genetic mutations. The …
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Get our free download! Implementing AMA Style – 8 Things to Get Right In this episode, we discuss the latest FDA approvals from June 12 – June 16, 2023. Here are the key highlights: · The FDA has granted accelerated approval to Roche's Columvi® (glofitamab) for the treatment of DLBCL and large B-cell lymphoma. · Linzess® (linaclotide) capsules have…
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This episode covers the latest FDA approvals from Jun 5 to Jun 9, 2023. Here are the key highlights: PREVYMIS (letermovir) has been approved by the FDA to prevent cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients, based on a phase 3 trial where it was found to be superior to valganciclovir in reducing the incidence of CM…
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Get our free download! Implementing AMA Style – 8 Things to Get Right This episode covers the latest FDA approvals from May 29 to Jun 2, 2023. Here are the key highlights: Pfizer's RSV vaccine, Abrysvo, has received FDA approval for use in adults aged 60 years or older, aimed at preventing lower respiratory tract disease caused by the RSV virus, ba…
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Get our free download! Implementing AMA Style – 8 Things to Get Right In this episode, we discuss the latest FDA approvals from May 22 to May 26, 2023. Here are the key highlights: Inpefa (sotagliflozin) has received FDA approval as a once-daily oral tablet for reducing the risk of cardiovascular death, hospitalization for heart failure, and urgent…
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Get our free download! Implementing AMA Style – 8 Things to Get Right Join medical writer Dr. Emma Hitt Nichols as she relays information about the latest new FDA approvals from last week to help you stay updated. For clinicians, medical writers, medical science liasons, pharma sales reps, and other healthcare industry executives. The FDA has appro…
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Get our free download! Implementing AMA Style – 8 Things to Get Right Join medical writer Dr. Emma Hitt Nichols as she relays information about the latest new FDA approvals from last week to help you stay updated. For clinicians, medical writers, medical science liasons, pharma sales reps, and other healthcare industry executives. The FDA has appro…
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In this episode, Alan G. Minsk, AGG Food & Drug team leader, and Anuj Desai, AGG Intellectual Property partner and head of Trademarks, discuss recent developments that remind our audience in the food and drug space that FDA is not the only regulatory agency that’s keeping an eye on the marketplace. Alan and Anuj look at how NAD, a BBB program that …
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