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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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AMA Update

American Medical Association

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AMA Update is your source for physician-focused news. Hear from physicians and other experts on trending public health concerns, practice issues, and more. Because who’s doing the talking matters. Find all AMA podcasts at ama-assn.org/podcasts.
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When a topic as complex as vaccines becomes socially taboo, where do you go to talk about it? Join pediatrician Dr. Bob Sears and Melissa, mother and health freedom educator, on this informative journey where we will discuss everything from disease outbreaks to vaccine risks and side effects, the vaccine schedule, media hype, vaccine laws and controversies, and everything in between. Learn more at our non-profit website ImmunityEducationGroup.org | Sources available at bit.ly/vaxconv . Suppo ...
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Each week the MPR team brings you the top stories from the world of medicine and pharma in a matter of minutes. With 35 years of publishing drug information behind us, you can rely on MPR to provide accurate and up-to-date news.
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The Real Deal Nurse Practitioner Club is the most inclusive exclusive hangout for nurse practitioners and aspiring nurse practitioners. Join your host Sarah Michelle MSN, APRN, FNP-C, FNP-BC, and co-host, Anna, as they and their guests dive deep into what you need to know before taking your exam, passing your exam, and becoming a real deal nurse practitioner! Each week they’ll cover topics such as how to pass your nurse practitioner exam the first time, overcoming test anxiety, writing your ...
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Is a new COVID vaccine coming out? Which RSV vaccine is better? Are there new PCV vaccines? Which vaccines can be given together? When is the new flu shot available? Our guest is Sandra Fryhofer, MD, AMA’s liaison to the Advisory Committee on Immunization Practices (ACIP), and a member of ACIP’s COVID-19 Vaccine Workgroup. American Medical Associat…
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There have been quite a few updates to certain vaccinations over the past several years, so Anna and I are here this week to review these important updates with you. Regardless of the population you care for, these vaccines are ones you’ll see in your clinical rotations or in practice, and you’ll probably be asked about them by your patients. Tune …
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Visit nascentmc.com for the full writup of this episode and medical writing assistance. Visit learnamastyle.com for free downloads directed towards medical writing and editing. • The FDA has approved the 21-valent pneumococcal conjugate vaccine, CAPVAXIVE™ (Merck), for the prevention of invasive disease and pneumonia in adults aged 18 years and old…
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Skyrizi has been approved for ulcerative colitis; New pneumococcal vaccine approved; An indictment may impact as much as 50,000 patients who need ADHD meds; Results announced for Moderna’s next-gen COVID-19 vaccine; Farxiga approval expanded.
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New steroid-free topical for atopic dermatitis; A refillable ocular implant for the treatment of neovascular (wet) age-related macular degeneration returns following recall; A neuroimmune modulation device shows clinical benefit in adults with rheumatoid arthritis; FDA denies Novo Nordisk’s once-weekly insulin icodec; And a smarthphone therapy show…
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What are the goals of the American Medical Association? Is Medicare unsustainable? Do doctors lose money on Medicare patients? What is the AMA position on prior authorization? Our guest is AMA Senior Vice President of Advocacy, Todd Askew. American Medical Association CXO Todd Unger hosts.🩺 The AMA is your powerful ally in patient care. Join now: h…
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What is the new COVID variant? How many variants are there? How long does long COVID last? How long do COVID GI symptoms last? Which states have bird flu? Our guest is AMA's Vice President of Science, Medicine and Public Health, Andrea Garcia, JD, MPH. American Medical Association CXO Todd Unger hosts.🩺 The AMA is your powerful ally in patient care…
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Anna and I are doing something new this week that we think you’ll love. We’re taking a slightly different approach to highlighting important clinical practice by sharing two patient vignettes we've encountered in our own clinical practice. We hope these scenarios help you become the best Nurse Practitioner possible. Join us on this episode as we sh…
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Visit learnamastyle.com for free downloads and free courses related to writing in medicine and science. - The FDA has approved donanemab (Kisunla) for early symptomatic Alzheimer's disease, making it the third drug in a new class aimed at slowing cognitive decline in early-stage patients. Eli Lilly will make the drug available within weeks followin…
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What is dengue fever? Is dengue fever deadly? How long does dengue fever last? Can dengue fever kill you? Is dengue fever in Florida? Our guest is AMA's Vice President of Science, Medicine and Public Health, Andrea Garcia, JD, MPH. American Medical Association CXO Todd Unger hosts.🩺 The AMA is your powerful ally in patient care. Join now: https://a…
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What is a value-based care model? Is value-based care the future? How does value-based care work? What is Risant Health and who is buying Cone Health? Our guest is Risant Health CEO Jaewon Ryu, MD. American Medical Association CXO Todd Unger hosts.🩺 The AMA is your powerful ally in patient care. Join now: https://ama-assn.co/JoinRenew 🎞️ Watch Dr. …
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Do you work for a CME company that needs urgent medical writing assistance? We can help. Visit nascentmc.com - The FDA has approved ensifentrine (Ohtuvayre) as an inhaled maintenance therapy for adults with COPD. Ohtuvayre is the first new mechanism of action for COPD treatment in over two decades, offering anti-inflammatory and bronchodilatory eff…
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New maintenance treatment approved for COPD; Authorized generic version of Victoza launches; Duchenne muscular dystrophy treatment indication expanded; Narcolepsy treatment expanded for certain pediatric patients; FDA clears digital therapeutic for ADHD.
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What is the cause of bird flu? How does bird flu spread to humans? Is bird flu contagious? What are the symptoms of avian flu in humans? Is milk safe to drink? Our guest is Jay Butler, MD, deputy director for infectious diseases at the CDC. American Medical Association CXO Todd Unger hosts.🩺 The AMA is your powerful ally in patient care. Join now: …
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COVID summer surge: Are COVID cases rising? Is there fake semaglutide? Is compounded tirzepatide the same as Mounjaro? Plus latest FDA VRBPAC Meeting 2024 news. Our guest is AMA's Vice President of Science, Medicine and Public Health, Andrea Garcia, JD, MPH. American Medical Association CXO Todd Unger hosts.🩺 The AMA is your powerful ally in patien…
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What is MDPP coverage for Medicare? Why is it important to catch diabetes early? Does Medicare cover A1c for prediabetes? Does Medicare cover diabetes prevention program?Our guest is Colleen Barbero, PhD, MPPA, model lead with the Centers for Medicare & Medicaid Services Innovation Center, and Kate Kirley, MD, MS, director of chronic disease preven…
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How to heal from physician burnout: Can a vacation help with burnout? How much vacation do doctors get? What are risk factors for burnout? Why do physicians leave their jobs? Our guest is Christine Sinsky, MD, vice president of Professional Satisfaction, at the American Medical Association. AMA CXO Todd Unger hosts.🩺 The AMA is your powerful ally i…
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Heat wave safety tips: How long will the heat wave last? What are the first signs of heat exhaustion? Can women get monkeypox? Is there bird flu in milk? Our guest is AMA's Vice President of Science, Medicine and Public Health, Andrea Garcia, JD, MPH. American Medical Association CXO Todd Unger hosts.🩺 The AMA is your powerful ally in patient care.…
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Who can join the AMA? What issues does the AMA fight for? How does the AMA affect healthcare policy? What are AMA Sections? How is the AMA organized? Our guests answer those questions and more at the 2024 Annual Meeting of the AMA House of Delegates. Adnan Munkarah, MD, is care delivery system president and chief clinical officer at Henry Ford Heal…
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Check out Nascentmc.com for medical writing assistance. visit learnAMAstyle.com for free downloads on medical writing and editing Adbry for Atopic Dermatitis The FDA has approved tralokinumab-ldrm (Adbry) as a 300 mg single-dose autoinjector for moderate-to-severe atopic dermatitis (AD) in adults, offering a more convenient delivery method. Adbry, …
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Two glucose monitoring systems have been cleared for over-the-counter sale; Arexvy gains approval for adults aged 50 to 59 years; Kevzara approved for active polyarticular juvenile idiopathic arthritis; Generic Duchenne muscular dystrophy drug is made available; and Iqirvo gets accelerated approval for primary biliary cholangitis.…
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How is bird flu transmitted? Is bird flu dangerous to humans? Are mushroom gummies safe? Why don't edibles list ingredients? What is the new AMA policy on public health? Our guest is AMA's Vice President of Science, Medicine and Public Health, Andrea Garcia, JD, MPH. American Medical Association CXO Todd Unger hosts.🩺 The AMA is your powerful ally …
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In honor of Pride Month this June, Anna is here this week to talk about inclusivity and how to exemplify that for the LGBTQIA+ community in healthcare. The LGBTQIA+ community is twice as likely to report discrimination by a healthcare provider than non-LGBTQIA+ people, among other chronic stressors that lead to stigmatization. As real-deal NPs, you…
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What does the AMA fight for? Why is prior authorization taking so long? What is the scope of practice for the American Medical Association? Our guest is the new president of the AMA, Bruce Scott, MD. American Medical Association CXO Todd Unger hosts.🩺 The AMA is your powerful ally in patient care. Join now: https://ama-assn.co/JoinRenew 💪 See how t…
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Nascentmc.com for medical writing assistance for your company. Visit learnAMAstyle.com for free downloads on medical writing and editing Klisyri for Actinic Keratosis: The FDA has approved tirbanibulin (Klisyri) for treating actinic keratosis (AK) on larger areas of the face or scalp, up to 100 cm². Previously approved for areas up to 25 cm² in Dec…
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AMA Senior Vice President of Advocacy, Todd Askew, provides an update at the AMA Annual Meeting on the advocacy efforts of the AMA so far this year on the top priorities for physicians. American Medical Association CXO Todd Unger hosts.🩺 The AMA is your powerful ally in patient care. Join now: https://ama-assn.co/JoinRenew 🤝 Learn more about grant …
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What is the CMS rule for prior authorizations? How is AI changing healthcare? Why is there a shortage of primary care physicians? What are the telehealth billing rules? Our guest is AMA President Jesse Ehrenfeld, MD, MPH. American Medical Association CXO Todd Unger hosts.🩺 The AMA is your powerful ally in patient care. Join now: https://ama-assn.co…
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Go here for complete show notes. Visit learnAMAstyle.com for free downloads on medical writing and editing Nascentmc.com for medical writing assistance for your company. mRESVIA for Lower Respiratory Tract Disease The FDA approved mRNA-1345 (mRESVIA) for preventing RSV-caused lower respiratory tract disease in adults 60 and older, based on Phase 3 …
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Extended-release ADHD treatment gains approval; An interchangeable biosimilar to Soliris is approved; Investigational treatment shows promise for improving depression and insomnia; The FDA vote on a blood-based colorectal cancer diagnostic; Survey reveals public attitudes towards the FDA.
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The Director of the Milner Centre for Evolution, Professor Turi King, talks to Associate Professor Stephanie Lo about her research into Pneumococcal diseases, the formulation of more effective vaccines and the impact those vaccines can have on reducing our reliance on antibiotics.By Milner Centre for Evolution
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How does bird flu spread to humans? Is raw milk safe to drink? What are the symptoms of bird flu in humans? Are STI rates increasing? Why are STIs on the rise?Our guest is AMA's Vice President of Science, Medicine and Public Health, Andrea Garcia, JD, MPH. American Medical Association CXO Todd Unger hosts.…
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Advanced care planning is about your patients planning for the care they want in advance, just in case they become so seriously ill that they’re unable to advocate for themselves. While it’s vital for you to have these conversations with your patients, it often feels overwhelming and intimidating, especially if you’re getting ready to head out into…
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What is the most trusted medical information source? Is semaglutide safe? What is the best treatment for obesity? How long can you be on semaglutide for weight loss?Our guest is Kirsten Bibbins-Domingo, MD, PhD, editor-in-chief of JAMA and the JAMA Network. American Medical Association CXO Todd Unger hosts.…
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Self-administered device cleared to treat stress urinary incontinence in women; Autoinjector warning for relapsing MS treatment; COVID-19 preexposure prophylaxis investigational treatment looks promising; Biosimilars for Eylea approved; Imdelltra approved for extensive stage small cell lung cancer with disease progression.…
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Why are doctors so burned out? How common is physician burnout? What causes physician burnout? Is physician burnout increasing? Why is physician wellness important?Our guest is chair of the AMA Board of Trustees Willie Underwood III, MD, MSc, MPH. American Medical Association CXO Todd Unger hosts.By American Medical Association
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For medical writing assistance, please visit nascentmc.com learnAMAstyle.com for the AI in Medical Writing and Editing: Blueprint for Success in a Changing World course to assist with implementing AI in medical writing. • Imdelltra for EC-SCLC: The FDA granted accelerated approval for tarlatamab-dlle (Imdelltra) for adults with extensive-stage smal…
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Reliability of COVID-19 tests unreliable; Insulin pump app updated following battery issue; Noninvasive colorectal cancer test gets FDA approval; Self-collection HPV screening option; National Drug Threat Assessment highlights illicit drugs currently endangering the US.
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Top health care cybersecurity issues: Why is healthcare data so valuable to hackers? When is it OK to reuse a password? Why are hospitals vulnerable to cyber attacks?Our guest is Charles Aunger, managing director of technology at Health2047 and founder and CEO of HEAL Security. American Medical Association CXO Todd Unger hosts.…
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Is bird flu spreading in US dairy cows? Is it safe to drink milk? Is COVID going around again? How dangerous is the new COVID variant? Is diarrhea a symptom of COVID? Our guest is AMA's Vice President of Science, Medicine and Public Health, Andrea Garcia, JD, MPH. American Medical Association CXO Todd Unger hosts.🩺 The AMA is your powerful ally in …
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Over the past couple of years, weight loss medications like Ozempic have skyrocketed in popularity, having gained the attention of celebrities and social media influencers for their seemingly magical weight loss powers. As a real-deal Nurse Practitioner, you must understand how these medications work in the body and how to safely prescribe them, an…
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Visit NascentMC.com for medical writing assistance. Visit learnAMAstyle.com for information on AI in Medical Writing and Editing - **mRNA Anti-EBV Cancer Vaccine**: The novel mRNA therapeutic cancer vaccine WGc-043 has been approved for clinical trials by the FDA, targeting Epstein-Barr virus (EBV) related cancers such as nasopharyngeal carcinoma a…
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What is the leading cause of physician burnout? What problems can AI solve in health care? Benefits of artificial intelligence in health care: How is AI used in EHR? Our guest is AMA President Jesse Ehrenfeld, MD, MPH. American Medical Association CXO Todd Unger hosts.🩺 The AMA is your powerful ally in patient care. Join now: https://bit.ly/AMAJoin…
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