rare-diseases

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

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

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

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

036 — 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

Here is information on the latest US FDA approvals, the week of January 22 - January 26, 2024Nascentmc.comChatGPT4 in medical writing and editing—visit learnAMAstyle.comcom for medical writing assistance for your…

Continue Reading036 — 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

035 — 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

Here is information on the latest US FDA approvals for the week of January 15 - January 19, 2024Erdafitinib for Urothelial CarcinomaThe FDA has granted full approval to erdafitinib (Balversa)…

Continue Reading035 — 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

032 — Potentially Practice-Changing Drugs Approved by the FDA in 2023

https://www.pharmacytimes.com/view/eleven-potentially-practice-changing-drugs-were-approved-by-the-fda-in-2023 Daprodustat (Jesduvroq; GSK) is an oral medication for treating anemia in adults undergoing hemodialysis due to chronic kidney disease (CKD). Unlike traditional treatments that rely on iron supplementation and erythropoiesis-stimulating…

Continue Reading032 — Potentially Practice-Changing Drugs Approved by the FDA in 2023

031 — 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; Sotorasib in NSCLC

Here is information on the latest US FDA approvals, the week of December 16 -  December 22, 2023. Test for Risk of Opioid Addiction The FDA has approved the first…

Continue Reading031 — 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; Sotorasib in NSCLC

029 — Iptacopan for PNH, Casgevy and Lyfgenia for Sickle Cell Disease, SGT-003 in Duchenne Muscular Dystrophy, New Fingerstick Blood Collection Device

Here is information on the latest US FDA approvals, the week of December 2 -  December 8, 2023 Iptacopan (Fabhalta) for PNH The FDA has approved iptacopan (Fabhalta) as the first…

Continue Reading029 — Iptacopan for PNH, Casgevy and Lyfgenia for Sickle Cell Disease, SGT-003 in Duchenne Muscular Dystrophy, New Fingerstick Blood Collection Device