United States Food and Drug Administration
FDA Pauses BioNTech’s Malaria Vaccine Trial Amid Regulatory Scrutiny
BioNTech, malaria vaccine, FDA clinical hold, RNA vaccine, regulatory challenges
Atara Biotherapeutics Halves Workforce Amid FDA Setbacks for Key Therapies
Atara Biotherapeutics, layoffs, FDA clinical hold, Ebvallo, ATA3219, manufacturing issues
FDA updates Boston Scientific’s Accolade pacemaker recall, reporting 832 injuries
United States Food and Drug Administration, Mental Recall, Preventive monitoring, trauma qualifier, Medical Devices, Artificial cardiac pacemaker
Compounders Sue FDA Over Removal of Semaglutide from Drug Shortage List
Semaglutide, FDA, drug shortage, compounders, lawsuit, Ozempic, Wegovy, Outsourcing Facilities Association
Hims eyes growth in its weight loss business, despite end of semaglutide shortage
semaglutide, weight loss business, United States Food and Drug Administration, Growth, Hims
FDA Moves to Rehire Some Recently Fired Employees Amid Backlash
FDA, layoffs, rehiring, Trump administration, medical device industry, public health agencies
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