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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Each week, a group of storytellers gathers around a campfire. There's world-weary club MC Edgar Allan Poe, nerd dad Stephen King, violent goth Mary Shelley, squid-obsessed wimp HP Lovecraft, and others. A comedy-horror semi-anthology adapted from Bitter Karella's Hugo-nominated microfiction.
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Seal of Approval is a music review podcast hosted by James Sanders and Jennifer Roger. We discuss what we're listening to, recent and historical events in music, as well as our lives. We are sharing, and we hope you will feel welcome to also.
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Two men named Dan and Harry adventure into the dense forests of societal norms, they quickly discover that people are stupid.
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From start to finish, the Twilight Zone remains one of the most compelling series in television history. In honor of the show, Brandon (of Apathetic Enthusiasm) and a variety of guests, both regular and special, watch the series from start to finish and discuss the characters, themes, and ideas Rod Serling brought to the screen. Submitted for Your Approval, we present to you, a Twilight Zone podcast.
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Fasenra Pediatric Asthma Expansion, Xcopri New Delivery Methods, New MRD Endpoint for Myeloma, Mpox PCR Test Home Collection Kit, Dovato for Adolescents With HIV
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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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Cilta-cel for Myeloma, Enhertu for HER2-positive Solid Tumors, Fanapt for Bipolar, Zevtera for Multiple Bacterial Infections, TriClip for Tricuspid Regurgitation, Revumenib for Acute Leukemia
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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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Winrevair for PAH, Vafseo for CKD, Ultomiris for NMOSD, Evolut FX+ for TAVR, Vemlidy for Pediatric HBV, Pemgarda for COVID
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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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Nexletol and Nexlizet for LDL Lowering and CV Risk, Iclusig for ALL, Elahere for Ovarian Cancer, Duvyzat for DMD, Spevigo for Psoriasis, Tryvio for Hypertension, Opsynvi for PAH, Lenmeldy for Juvenile ...
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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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Liso-cel for CLL/SLL, Tislelizumab for Esophageal SCC, Resmetirom for NASH, Maralixibat for Cholestatic Pruritus, Guselkumab for UC
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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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OTC Glucose Monitor, Semaglutide and CVD risk, Juvederm Additional Indication, Nivolumab in mUC, Zanubrutinib in FL, Donanemab and Alzheimer’s, Tocilizumab Biosimilar, Denosumab Biosimilars, Clobetasol ...
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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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Amivantamab for NSCLC, Drug-Coated Balloon for ISR, Ibrutinib Oral Suspension, Epcoritamab for Follicular Lymphoma, Govorestat for Galactosemia, Obeticholic Acid for PBC, Biktarvy for HIV, Roluperidone ...
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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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Enmetazobactam for cUTI, Dupilumab for COPD, Melphalan Flufenamide Withdrawal, Teclistamab Biweekly Dosing, Linvoseltamab in RRMM
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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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Lifileucel for Melanoma, Iloprost for Frostbite, MDMA-Assisted Therapy for PTSD, NALIRIFOX for Pancreatic Cancer, Tepotinib for NSCLC, Omalizumab for Food Allergies, Budesonide for EOE, Tricuspid Regurgitation ...
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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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Eplontersen for ATTR-CM, Nivolumab for NSCLC, RSV Vaccine for Adults Aged 50 to 59, Spinal Cord Stimulation System for NSBP, OK-101 for Neuropathic Corneal Pain, Viz ICH Plus for Brain Bleed, Vepdegestrant ...
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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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Tricuspid Valve Replacement System, Afami-Cel for Synovial Sarcoma, Pulsed Field Ablation for Atrial Fibrillation, Shorter Turnaround Time for Axi-cel, AI Algorithm for Cervical Cancer, Trastuzumab Deruxtecan ...
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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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Boxed Warning for CAR-T Cell Therapy, Dupilumab for Pediatric EOE, Wearable Device for Osteopenia, BSI-082 IND for Solid and Liquid Tumors, VCA-894A for Charcot Marie-Tooth, FDA Roundup
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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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Erdafitinib for Urothelial Carcinoma, TTFields in NSCLC, AI-Powered Device to Detect Skin Cancer, Casgevy for Beta Thalassemia, HyQvia for CIDP, Physicians' Understanding of FDA Approval Process
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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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Berdazimer for Molluscum Contagiosum; Pembrolizumab for Cervical Cancer; GLP-1 RAs and Suicidal Thoughts; Cognitive Impairment Test; SH-105 for Breast and Ovarian Cancer; DBS System for Parkinson’s; NexoBrid ...
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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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FDA Approves First State Request to Import Drugs From Canada and 5 Upcoming FDA Approvals
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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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Test for Opioid Addiction; Filsuvez for Epidermolysis Bullosa; Budesonide for IgAN; Eplontersen for hATTR-PN; NRX-101 for complicated UTI; Gefapixant for Chronic Cough; V116 for Invasive Pneumococcal Disease; ...
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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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The Tale of the Tell-Tale Heart
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Low-budget movie mogul Roger Corman sets out to produce a papier maché blockbuster adaptation of Edgar Allan Poe's classic tale of psychological suspense. Loosely following the plot of the original, Poe is tasked with taking care of a Scottish castle belonging to a certain formerly popular children's author. But uh oh! His wacky pal Stephen King ar…
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Belzutifan for RCC; AFib Ablation; Roflumilast for Seborrheic Dermatitis; Eflornithine for Neuroblastoma; Isavuconazonium Sulfate For Pediatric Patients; Travoprost Intracameral Implant for Glaucoma; AR ...
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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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The Tale of the Snow Woman
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It's winter at the campfire, and that means one thing—snow-themed holiday special! The Midnight Pals are visited by Junji Ito, adorable catboy and terrifying master of fucked-up-face-filled manga horror, accompanied by original weeaboo Lafcadio Hearn. The pair narrate an ancient Japanese folktale of ripped samurai, distressed noblewomen, and season…
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Iptacopan for PNH, Casgevy and Lyfgenia for Sickle Cell Disease, SGT-003 in Duchenne Muscular Dystrophy, New Fingerstick Blood Collection Device
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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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The Tale of the Nightbreed
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Clive Barker takes the stage and relates his cult classic of an eternal battle—gay monsters versus redneck cops. Cabal has always had unsettling dreams of becoming a gay monster, but his personal journey to gay monsterhood is obstructed by queer-gatekeeping monsters, Nazi sheriffs' departments, and unconvincing gimp-mask serial killer David Cronenb…
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Nirogacestat For Desmoid Tumors, Pirtobrutinib for CLL/SLL, Enfortumab Vedotin With Pembrolizumab for UC, Lisocabtagene Maraleucel for CLL/SLL, Xanomeline-trospium for Schizophrenia, Roflumilast for AD ...
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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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The Tale of the Strangers on a Train
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Patricia Highsmith, crime writer, snail friend, and lovable weirdo known for her shabby trenchcoat, eccentric habits, and possibly imaginary wife, investigates a bizarre double murder. Two people who don't know each other, or if you will, "strangers", meet on a rail vehicle, or as it were, "train", and plan the perfect crime. What really happened w…
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The Tale of Sherlock Holmes and the Case of the Midnight Society
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Arthur Conan Doyle stumbles upon the Midnight Pals' storytelling circle and reluctantly agrees to bring beloved supersleuth Sherlock Holmes back for one last, final, final case. A locked-room murder mystery turns to metafictional highjinks as the Pals are embroiled in the world of Holmes's adventures, sort of like when the holodeck malfunctions on …
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Capivasertib for Breast Cancer, Repotrectinib for NSCLC, Enzalutamide for Prostate Cancer, Pembrolizumab for Stomach Cancer, Hypertension Device
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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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Neurotic closet-dweller Bram Stoker visits the campfire to tell his iconic vampire story. In Transylvania, hot twink Jon "Jonathan" Harker shacks up with a rich older man who wants to consume his bodily fluids. Meanwhile in England, notorious strumpet Lucy Westenra attempts to ensnare her innocent friend Mina into the dangerous and disgusting world…
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Tirzepatide for Obesity, Ixchiq Chikungunya Vaccine, fruquintinib for mCRC, Adzynma (ADAMTS13, recombinant-krhn) for cTTP
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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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The Tale of Dr Jekyll and Mr Hyde
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A new candidate for the Midnight Society, insufferable San Francisco hipster Robert Louis Stevenson, attempts to impress the Pals with the story of Henry Jekyll, a Victorian psychiatrist. On the steamship home from a business trip, Jekyll's seemingly chance meeting with a certain Edward Hyde will change his perception of reality forever. In a twist…
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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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The Tale of the Frankenstein
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Mary Shelley tells her Midnight Pals a chilling tale about a brilliant young researcher, Victor, whose arrogance leads him to pursue a deadly ambition. The experiment has been attempted by generations of mad scientists, but never successfully accomplished: the creation of a Frankenstein! Stephen King gets pedantic about terminology. Content notes: …
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Bimzelx (bimekizumab); Keytruda (pembrolizumab); Opdivo (nivolumab); Zilbrysq (zilucoplan); and more
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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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It's Bram Stoker's turn at the campfire and he's brought a new story, "The Tale of The—" oh dear, we might have to do something about that title. Content notes: Discussion of racism; human and animal death; discussion of violence and torture. Season 1 Premiere: Our first full episode, The Tale of the Frankenstein, will release on our podcast feed o…
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Midnight Snacks: 11 teaser mini-episodes
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The main characters of Midnight Pals, plus a few regular visitors to the campfire, introduce themselves with a series of short skits based on their most popular works. A medley of midnight-snack size tales from Stephen King, Mary Shelley, HP Lovecraft, Clive Barker, Dean Koontz, Edgar Allan Poe and more. This is a consolidation of the first eleven …
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Velsipity (Etrasimod) for UC; Braftovi (encorafenib) and Mektovi (binimetinib) for NSCLC; Patisiran in ATTR amyloidosis; Digital Health Advisory Committee
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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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Novavax COVID Vaccine, Rivfloza (Nedosiran) for Primary Hyperoxaluria, Intravenous Cosentyx, Abrilada Adalimumab Biosimilar, Large Volume On-Body Injector
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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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Ryzumvi Mydriasis Reversal Drops, Exxua for MDD, Likmez Metronidazole Liquid Formulation, DNA Test for Hereditary Cancers, Tofidence Actemra Biosimilar, Pompe Disease Combination Therapy, Subcutaneous ...
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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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Jardiance (empagliflozin) for CKD, Welireg (belzutifan) for RCC, Tevimbra (tislelizumab) for Esophageal Squamous Cell Carcinoma, Neffy Epinephrine Nasal Spray
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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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Ojjaara for Anemia in Myelofibrosis, Resmetirom for NASH, COVID-19 Vaccine Update, Phenylephrine, Patisiran in ATTR-CM
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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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Ilaris for Gout, Generics for ADHD, Balversa for Urothelial Cancer, INO-3107 for Recurrent Respiratory Papillomatosis, Crovalimab for PNH
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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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Living and dead horror authors tell scary stories round the campfire in "Submitted for the Approval of the Midnight Pals", an upcoming audio adaptation of Bitter Karella's Hugo-nominated comedy-horror microfiction. Full episodes start releasing on October 31, 2023, with an early premier and cast chat streaming on Twitch on Sunday October 29th. For …
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New MS Biosimilar, RSV Maternal Immunization, Rybrevant in Advanced NSCLC, Xtandi in Early PCa
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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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Myeloma Bispecific, Uveal Melanoma, HD Eylea, Huntington's, Fibrodysplasia Ossificans Progressive, CHAPLE Disease
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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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RiVive, Balfaxar, Xdemvy
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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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