United States Food and Drug Administration
FDA Approves Extended Dosing for Astellas’ Izervay, Intensifying Competition in Geographic Atrophy Treatment
Izervay, Astellas, FDA approval, extended dosing, geographic atrophy, age-related macular degeneration, Syfovre, Apellis, eye treatment
FDA Approves Pfizer’s Adcetris Combination Therapy for Relapsed/Refractory Large B-cell Lymphoma
Adcetris, brentuximab vedotin, FDA approval, large B-cell lymphoma, LBCL, DLBCL, antibody-drug conjugate, Pfizer, combination therapy
FDA Approves Extended Dosing for Astellas’ Izervay in Geographic Atrophy Treatment
Izervay, avacincaptad pegol, geographic atrophy, age-related macular degeneration, FDA approval, extended dosing, Astellas Pharma
FDA Approves Evrysdi Tablets: A Breakthrough in Convenient SMA Treatment
Evrysdi, risdiplam, spinal muscular atrophy (SMA), FDA approval, tablet formulation, oral treatment, Genentech, Roche
SpringWorks Therapeutics Secures FDA Approval for Gomekli to Treat NF1-Related Tumors
SpringWorks Therapeutics, Gomekli, mirdametinib, FDA approval, neurofibromatosis type 1 (NF1), plexiform neurofibromas (PN), rare disease treatment, MEK inhibitor
Gilead Sciences Prepares for Summer 2025 Launch of Long-Acting HIV Prevention Drug Lenacapavir
Gilead Sciences, lenacapavir, HIV prevention, PrEP, long-acting injectable, FDA approval, HIV sales, clinical trials, PURPOSE studies
FDA Approves SpringWorks’ Gomekli for Adult and Pediatric NF1-PN Patients
Gomekli, mirdametinib, neurofibromatosis type 1, plexiform neurofibromas, FDA approval, SpringWorks Therapeutics, MEK inhibitor
Vertex COO Stuart Arbuckle to Retire as Company Launches Groundbreaking Pain Drug Journavx
Vertex Pharmaceuticals, Stuart Arbuckle, retirement, Journavx, non-opioid pain medication, FDA approval, acute pain treatment
FDA Issues Import Alerts for Two Chinese API Manufacturers Following Failed Inspections
FDA, import alert, Chinese API manufacturers, failed inspections, quality control, Wuhu Nuowei Chemistry, Chengdu Innovation Pharmaceutical
Hims & Hers Super Bowl Ad Sparks Controversy Over Weight Loss Drug Marketing
Hims & Hers, Super Bowl ad, weight loss drugs, FDA scrutiny, compounded GLP-1 drugs, pharmaceutical advertising, telehealth, consumer safety