cancer

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…

Continue Reading048 — 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

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, 2024visit learnAMAstyle.com Fasenra Pediatric Asthma ExpansionThe FDA has approved benralizumab (Fasenra) for add-on maintenance…

Continue Reading047 — Fasenra Pediatric Asthma Expansion, Xcopri New Delivery Methods, New MRD Endpoint for Myeloma, Mpox PCR Test Home Collection Kit, Dovato for Adolescents With HIV

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, 2024Cilta-cel for MyelomaThe FDA has approved ciltacabtagene autoleucel (Carvykti; cilta-cel) for the treatment…

Continue Reading046 — 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

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, 2024Nexletol and Nexlizet for LDL Lowering and CV Risk, Iclusig for ALL, Elahere…

Continue Reading044 — 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

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, 2024Liso-cel for CLL/SLL, Tislelizumab for Esophageal SCC, Resmetirom for NASH, Maralixibat for Cholestatic…

Continue Reading043 — Liso-cel for CLL/SLL, Tislelizumab for Esophageal SCC, Resmetirom for NASH, Maralixibat for Cholestatic Pruritus, Guselkumab for UC

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…

Continue Reading042 — 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

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, 2024Amivantamab for NSCLCThe FDA has approved amivantamab (Rybrevant) in combination with chemotherapy (carboplatin-pemetrexed)…

Continue Reading041 — 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

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…

Continue Reading040 — Enmetazobactam for cUTI, Dupilumab for COPD, Melphalan Flufenamide Withdrawal, Teclistamab Biweekly Dosing, Linvoseltamab in RRMM

039 — Lifileucel for Melanoma, Iloprost Injection for Frostbite, MDMA-Assisted Therapy for PTSD, NALIRIFOX for Pancreatic Cancer, Tepotinib for NSCLC, Omalizumab for Food Allergies, Budesonide Oral Suspension for EOE, TriClip® for Tricuspid Regurgitation, ACE2016 for Solid Tumors, Human Acellular Vessel (HAV) for Vascular Trauma

00:00:00 Here is information on the latest US FDA approvals, the week of February 12 – February 16, 2024 Amtagvi for Melanoma The FDA has granted accelerated approval of lifileucel…

Continue Reading039 — Lifileucel for Melanoma, Iloprost Injection for Frostbite, MDMA-Assisted Therapy for PTSD, NALIRIFOX for Pancreatic Cancer, Tepotinib for NSCLC, Omalizumab for Food Allergies, Budesonide Oral Suspension for EOE, TriClip® for Tricuspid Regurgitation, ACE2016 for Solid Tumors, Human Acellular Vessel (HAV) for Vascular Trauma

038 — 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 for MBC, VerTouch Spinal Puncture Device

Here is information on the latest US FDA approvals for the week of February 5–9, 2024Eplontersen for ATTR-CMEplontersen (Wainua) has been granted Fast Track designation by the FDA for the…

Continue Reading038 — 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 for MBC, VerTouch Spinal Puncture Device