United States Food and Drug Administration
FDA Leaders Anticipate Imminent Drug Approval Decisions
FDA; drug approval; PDUFA date; regulatory decision; upcoming approvals; FDA leadership
FDA Reinstates Generic Drug Policy Group After April Firings
FDA; generic drugs; policy office; Division of Policy Development; reinstatement; layoffs; drug prices; administrative leave
Merck Wins FDA Approval for RSV Antibody Drug, Intensifying Market Competition
Merck; FDA approval; RSV; monoclonal antibody; infants; Enflonsia; competitive market; Sanofi; AstraZeneca
New Rules and Regulatory Trends in Biopharma Manufacturing in 2025
biopharma manufacturing; 2025 regulations; FDA; digital quality systems; green manufacturing; import rules; Trump administration tariffs; country-of-origin labeling; forced labor compliance; serialization
FDA Places Clinical Hold on Five Gilead HIV Studies Due to Safety Concerns
FDA; Gilead Sciences; HIV; clinical hold; GS-1720; GS-4182; clinical trials; safety signal; CD4+ T-cell; lymphocyte count; Biktarvy; lenacapavir
Insmed’s TPIP PAH Therapy Advances to Phase III Following Positive Phase 2b Results
Insmed; TPIP; treprostinil palmitil inhalation powder; pulmonary arterial hypertension; PAH; Phase 2b trial; Phase III trial; clinical trial results; FDA engagement
Axsome Plots New Fibromyalgia Trial After FDA Refuses Review of Former Pfizer Candidate
Axsome Therapeutics; esreboxetine; fibromyalgia; FDA; refusal to file; clinical trial; Pfizer; AXS-14; trial design; pain medicine
Merck’s Enflonsia FDA Approval Spurs Sanofi to Accelerate Beyfortus Supply Ahead of 2025-26 RSV Season
RSV; Infant immunization; Merck; Sanofi; Beyfortus; Enflonsia; FDA approval; supply chain; healthcare; AstraZeneca
Otsuka’s Phase 3 IgAN Win with Sibeprenlimab Shakes Vera’s Stock
Otsuka; sibeprenlimab; IgA nephropathy; phase 3 trial; proteinuria reduction; Vera Therapeutics; stock drop; kidney disease; UPCR; FDA Priority Review
Biotech Leaders Urge FDA to ‘Modernise’ Regulation to Compete with China
FDA; biotech; regulation; modernization; China; cell and gene therapy; CEO roundtable; competitiveness; innovation