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.
048 — Beqvez for Hemophilia B, Anktiva for Bladder Cancer, Pivya for UTI, Tovorafenib for Pediatric Low-Grade Glioma, Entyvio Maintenance for Crohn’s Disease, Alecensa for NSCLC, SPG601 for Fragile X Syndrome, Lumisight for Visualizing Breast Cancer
Beqvez for Hemophilia BThe FDA has approved fidanacogene elaparvovec-dzkt (Beqvez), a gene therapy, for adults with moderate to severe hemophilia B who meet certain criteria. Beqvez is a one-time treatment designed to enable patients to produce the clotting protein factor
047 — Fasenra Pediatric Asthma Expansion, Xcopri New Delivery Methods, New MRD Endpoint for Myeloma, Mpox PCR Test Home Collection Kit, Dovato for Adolescents With HIV
Here is information on the latest US FDA approvals, the week of April 8 – April 12, 2024 visit learnAMAstyle.com Fasenra Pediatric Asthma ExpansionThe FDA has approved benralizumab (Fasenra) for add-on maintenance treatment for patients with severe asthma aged 6
046 — 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
Here is information on the latest US FDA approvals, the week of April 1 – April 5, 2024 Cilta-cel for MyelomaThe FDA has approved ciltacabtagene autoleucel (Carvykti; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma
045 — Winrevair for PAH, Vafseo for CKD, Ultomiris for NMOSD, Evolut FX+ for TAVR, Vemlidy for Pediatric HBV, Pemgarda for COVID
Here is information on the latest US FDA approvals, the week of March 25 – March 29, 2024 Winrevair for PAHThe FDA has approved sotatercept-csrk (Winrevair) for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO]
044 — 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 Metachromatic Leukodystrophy
Here is information on the latest US FDA approvals, the week of March 18 – March 22, 2024 Nexletol and Nexlizet for LDL Lowering and CV Risk, Iclusig for ALL, Elahere for Ovarian Cancer, Duvyzat for DMD, Spevigo for Psoriasis,
043 — Liso-cel for CLL/SLL, Tislelizumab for Esophageal SCC, Resmetirom for NASH, Maralixibat for Cholestatic Pruritus, Guselkumab for UC
Here is information on the latest US FDA approvals, the week of March 11 – March 15, 2024 Liso-cel for CLL/SLL, Tislelizumab for Esophageal SCC, Resmetirom for NASH, Maralixibat for Cholestatic Pruritus, Guselkumab for UC Liso-cel for CLL/SLLThe FDA
042 — 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 Propionate Eye Drops
OTC Glucose MonitorThe FDA has cleared Dexcom Stelo Glucose Biosensor System for over-the-counter (OTC) sale, a first in the agency’s history for a continuous glucose monitor (CGM). This clearance follows Dexcom’s submission of the application on January 8, 2024. The
041 — 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 for Schizophrenia
Here is information on the latest US FDA approvals, the week of February 26 – March 1, 2024 Amivantamab for NSCLCThe FDA has approved amivantamab (Rybrevant) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced
040 — Enmetazobactam for cUTI, Dupilumab for COPD, Melphalan Flufenamide Withdrawal, Teclistamab Biweekly Dosing, Linvoseltamab in RRMM
Here is information on the latest US FDA approvals, the week of February 19 – February 23, 2024 ChatGPT4 in medical writing and editing—visit learnAMAstyle.com com for medical writing assistance for your company. Enmetazobactam for cUTI, Dupilumab for COPD, Melphalan