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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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The Vaccine Conversation with Melissa and Dr. Bob

Immunity Education Group

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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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Milner Centre for Evolution

Milner Centre for Evolution

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The Milner Centre for Evolution has three main objectives, to ask the big evolutionary questions, to find new technological and clinical applications, and to take evolutionary research out into the community.
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Real Deal Nurse Practitioner Club

Sarah Michelle and Anna

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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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The Director of the Milner Centre for Evolution, Professor Turi King, talks to Professor Andrew Preston about his research into the group of organisms called Bordetella. The most prominent member of the Bordetella group is Pertussis which causes Whooping cough, a disease that is on the rise again.Milner Centre for Evolution
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As real-deal Nurse Practitioners, delivering bad news to patients is an inevitable part of the job that we must be prepared for. But how can we have these difficult conversations in a way that provides clarity and compassion to our patients? Anna and I are here this week to share tips on how to prepare yourself before the conversation, create a sup…
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Use AI to Speed up Your Work Flow Ethically and Securely. There are lots of courses on AI out there, but this one is specific only to medical writing and editing. Access the AIMWE course waitlist. https://www.learnamastyle.com/waitlist/ Leqselvi for Alopecia Areata: The FDA has approved deuruxolitinib (Leqselvi) as a first-line treatment for adults…
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The Director of the Milner Centre for Evolution, Professor Turi King, talks to Dr Benjamin Padilla-Morales about the research paper he is first author on, and that has just been published in Nature Communications, titled: Sexual size dimorphism in mammals is associated with changes in the size of gene families related to brain development.…
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If the legal jargon in your contract leaves you feeling scared and intimidated, you’re not alone. Sure, you want to make sure you’re being adequately compensated through your salary, but what about work-life balance or the goals you want to achieve in your new position? Having your own back through this process is challenging, and that’s why Anna a…
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Visit learnAMAstyle.com to uplevel your writing and editing skills with free downloads on medical writing and editing. The FDA has approved vonoprazan (Voquenza) for treating non-erosive gastroesophageal reflux disease (GERD) in adults. Vonoprazan is an oral potassium-competitive acid blocker (PCAB) already approved for erosive esophagitis and Heli…
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Visit learnAMAstyle.com for free downloads in writing in medicine and the life sciences.  The FDA has approved blinatumomab (Blincyto) for treating adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase. This bispecific T-c…
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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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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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Professor Turi King discusses the career of developmental geneticist Professor Dr Christiane Nüsslein-Volhard, and how her passion for genetic analysis led to her 1995 Nobel Prize for Physiology or Medicine.Milner Centre for Evolution
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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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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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The Director of the Milner Centre for Evolution, Professor Turi King, talks to Professor Tiffany Taylor about her research which centres on three main and interlinking areas, experimental evolution, gene networks and bacterial defences.Milner Centre for Evolution
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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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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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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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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.Milner Centre for Evolution
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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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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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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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Please visit Nascentmc.com for medical writing assistance for your company. Visit learnAMAstyle.com for free downloads on medical writing and editing Ingrezza for Huntington’s: The FDA has approved valbenazine (INGREZZA® SPRINKLE) capsules for adults with tardive dyskinesia and chorea associated with Huntington's disease. This new oral granules for…
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You can probably remember how intimidating and overwhelming it was in your very first job as a new nurse, and starting out in your Nurse Practitioner career is no different. You’re learning new skills with a higher level of responsibility and liability, so if you’re not yet walking around with the confidence of a seasoned NP, you’re not alone. Anna…
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VIsit Nascentmc.com for medical writing assistance. Visit learnamastyle.com for freebies on medical writing and editing and ChatGPT. - Fasenra Pediatric Asthma Expansion: No details provided for this update. - Beqvez for Hemophilia B: FDA approved gene therapy, Beqvez, for adults with moderate to severe hemophilia B, which enables the production of…
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This week, Anna is speaking with the founder and CEO of NPHub, Krish Chopra. They are the best in the industry when it comes to finding Nurse Practitioner clinical placements, and they have a quality control process in place that prioritizes the well-being of both students and preceptors. That's why we’ve launched a partnership with them. Learn how…
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Visit nascentmc.com/podcast for full show notes. - The FDA has expanded the approval of benralizumab (Fasenra) to include children aged 6 to 11 with severe eosinophilic asthma, building on its previous approval for patients aged 12 and older. Benralizumab is a monoclonal antibody that targets and reduces eosinophilic inflammation, crucial in the se…
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· Nascentmc.com for medical writing assistance for your company.Visit nascentmc.com/podcast for full show notes Cilta-cel for Myeloma: The FDA approved ciltacabtagene autoleucel (Carvykti; cilta-cel) for adults with relapsed or refractory multiple myeloma who have tried at least one prior therapy including a proteasome inhibitor and an immunomodula…
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The Director of the Milner Centre for Evolution, Professor Turi King, talks to Jonathan Milner about the origins of his passion for evolution, and his reasons for setting up the Milner Centre for Evolution at the University of Bath.Milner Centre for Evolution
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Diagnostic reasoning is an essential skill for Real Deal Nurse Practitioners. A misdiagnosis can lead to unnecessary treatments, delayed treatment, and ultimately cause undue harm and stress to our patients. A major part of our role as NPs is diagnosing conditions, so we need to ensure our diagnoses are accurate. Tune in this week for a vital overv…
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Visit nascentmc.com/podcast for full show notes Winrevair for PAH: Sotatercept-csrk (Winrevair) is FDA-approved for treating adults with pulmonary arterial hypertension (PAH), enhancing exercise capacity, improving WHO functional class, and reducing clinical worsening events. It's the first FDA-approved activin signaling inhibitor for PAH, addressi…
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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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If you’re currently a future real-deal Registered Nurse, this is a must-listen episode. After studying, going through courses, clinical work, and approaching graduation, prepping for the NCLEX can often feel like you’re starting right back at the beginning. That’s why feeling supported throughout your journey is essential, and we’re here to share h…
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I'm Sarah Michelle, a host of the Real Deal Nurse Practitioner Club and I'm on a mission to get more nurse practitioners licensed and practicing in the field than ever before. We created this podcast for students and new nurse practitioners who have struggled with the pressure and the anxiety, preparing for their board exams and then entering into …
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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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For those of you who aren’t familiar, my daughter Meadow was born with a severe congenital heart defect last year. Being an advocate for congenital heart disease feels like the most special and important thing I can do as a Heart Mom, and sharing more about this is exactly what I felt called to do this Heart Month. I share some statistics on congen…
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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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There are many unique and amazing opportunities out there for Nurse Practitioners when it comes to global health. The great news is that because global health is a top priority, there are several resources available for exploration. Anna and I are here this week to guide you through the ins and outs of your global health journey. Hear how Nurse Pra…
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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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Transitioning from nurse to Nurse Practitioner is a big deal. It’s truly a whole new career. You’ve passed your boards, graduated from school, and now, you’re a real-deal NP. However, you’re not alone if self-doubt and fear are coming up for you. That’s why Anna and I are here this week to share our top tips on how to succeed on your first day as a…
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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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No matter what kind of Nurse Practitioner you are, you likely work alongside hospitalists, nurses, case managers, social workers, specialists, and ancillary staff. The unifying thread between all of you is to create a positive patient experience and to provide excellent care. How can we, as real-deal Nurse Practitioners, contribute to the ever-evol…
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