United States Food and Drug Administration
Pfizer taps former FDA drug chief Cavazzoni as new CMO
United States Food and Drug Administration, Pfizer, Cavazzoni, Center for Drug Evaluation and Research, Appointments, President brand of dental material
Entrada given go-ahead to test DMD therapy after two-year hold
Entrada, Muscular Dystrophy, Duchenne, DMD, United States Food and Drug Administration, Adult, Exons
FDA Approves Label Changes for Indivior’s Sublocade, Enhancing Treatment Accessibility for Opioid Use Disorder
Sublocade, FDA approval, rapid initiation protocol, alternative injection sites, opioid use disorder treatment
FDA Lifts Clinical Hold on Entrada’s Duchenne Muscular Dystrophy Drug ENTR-601-44 After Two Years
Duchenne muscular dystrophy, ENTR-601-44, Entrada Therapeutics, FDA, clinical hold, exon 44 skipping, ELEVATE-44-102, Phase 1b trial
FDA Reverses Course, Rehires Hundreds of Recently Fired Probationary Workers
FDA, probationary workers, rehiring, mass layoffs, federal agencies, Trump administration, Department of Health and Human Services (HHS)
FDA Approves Mirum’s Ctexli as First Treatment for Rare Lipid Disorder CTX
Ctexli, chenodiol, cerebrotendinous xanthomatosis (CTX), FDA approval, Mirum Pharmaceuticals, rare metabolic disorder, lipid storage disease, bile acid therapy
BridgeBio’s Attruby Gains FDA Approval, Challenging Pfizer’s Tafamidis in ATTR-CM Treatment
Attruby, acoramidis, BridgeBio, ATTR-CM, tafamidis, Pfizer, FDA approval, transthyretin stabilizer, cardiomyopathy
GSK’s Penmenvy Approved: New 5-in-1 Meningococcal Vaccine Enters U.S. Market
Penmenvy, GSK, meningococcal vaccine, FDA approval, 5-in-1 vaccine, MenABCWY, invasive meningococcal disease (IMD)
Bavarian Nordic’s Vimkunya Approved by FDA as First Chikungunya Vaccine for Ages 12 and Up
Vimkunya, chikungunya vaccine, Bavarian Nordic, FDA approval, virus-like particle vaccine, adolescents, travelers
FDA Approves Ono Pharmaceutical’s Romvimza for Rare Joint Tumor
Romvimza, tenosynovial giant cell tumor (TGCT), FDA approval, Ono Pharmaceutical, Deciphera acquisition, kinase inhibitor, rare cancer treatment