Disease or Syndrome
Aldeyra hopes new data for dry-eye disease drug will satisfy FDA
United States Food and Drug Administration, Aldeyra, reproxalap, Approved, Dry Eye Syndromes, Clinical Trials, New Drug Application
States sue US over plan for reorganization of federal health agencies
HHS reorganization, RFK Jr., lawsuit, mass layoffs, constitutionality, federal health agencies, state attorneys general
Eli Lilly licenses early-stage ALS drug program from Alchemab in $415M pact
Amyotrophic Lateral Sclerosis, Alchemab, Eli, Eli Lilly
Over 500 BMS jobs axed in latest round of NJ cuts
Bristol Myers Squibb (BMS), Layoffs, New Jersey, Lawrenceville campus, Worker Adjustment and Retraining Notification (WARN), Pharmaceutical industry job cuts, Employment reduction
Recursion’s homegrown assets hardest hit in AI-discovered pipeline cull
Recursion, homegrown, assets
J&J’s $130M gene therapy bet flunks rare retinal disease trial
Johnson & Johnson, gene therapy, bota-vec, X-linked retinitis pigmentosa, Phase 3 failure, vision loss treatment, rare eye disease, $130 million investment
Novo eyes fourth-quarter FDA verdict for oral Wegovy filing
Obesity, Novo, United States Food and Drug Administration, Decision, Oral cavity, Wegovy, semaglutide, Overweight
FDA delays decision date on Cytokinetics’ heart drug to year-end in unusual safety program back-and-forth
Cytokinetics, aficamten, FDA delay, PDUFA date extension, hypertrophic obstructive cardiomyopathy (oHCM), Risk Evaluation and Mitigation Strategy (REMS), regulatory setback
FDA frees Amgen’s phase 1 obesity asset from clinical trial hold
Obesity, United States Food and Drug Administration, Amgen, MariTide, Study on Hold, Participant
FDA withdraws two final guidances, pulls compliance deadlines for bone allograft makers
United States Food and Drug Administration, Allogeneic bone graft, Mycobacterium tuberculosis, guidances, Disease Outbreaks, standards characteristics