February 2025
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 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
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)
Bluebird Bio’s Fall from Grace: Gene Therapy Pioneer Sells for $29M After $10B Valuation
Bluebird Bio, gene therapy, private equity, Carlyle, SK Capital, financial challenges, acquisition, biotech industry
Major Clinical Trial Failures of 2024: Setbacks in Neuroscience and Beyond
Clinical trials, drug development, neuroscience, ALS, Alzheimer’s disease, schizophrenia, Duchenne muscular dystrophy, oncology
CDC Vaccine Advisory Committee Meeting Postponed Following RFK Jr.’s Confirmation as HHS Secretary
ACIP, CDC, vaccine recommendations, Robert F. Kennedy Jr., HHS, postponement, public health, immunization policy
BioMarin’s R&D Chief Warns of Innovation Slowdown Amid NIH Funding Cuts
BioMarin, NIH funding, biomedical innovation, genetic diseases, drug development, research partnerships
Gilead’s Seladelpar Receives Conditional EU Approval for Primary Biliary Cholangitis Treatment
Seladelpar, Gilead Sciences, primary biliary cholangitis, PBC, European Commission, conditional marketing authorization, RESPONSE trial, ursodeoxycholic acid (UDCA)