United States Food and Drug Administration
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
Biogen says Leqembi sales are improving slowly following lackluster launch
Leqembi, Biogen, Sales – occupational activity, Growth, Eisai, United States Food and Drug Administration, Improving (qualifier value)
FDA Approves Johnson & Johnson’s Imaavy: A New Treatment Option for Generalized Myasthenia Gravis
Imaavy, nipocalimab-aahu, FcRn blocker, generalized myasthenia gravis (gMG), FDA approval, Johnson & Johnson, autoimmune disease, IgG reduction
Entrada tightens focus on Duchenne, axes 20% of staff
Duchenne muscular dystrophy (DMD), workforce reduction, ENTR-601-44, ENTR-601-45, FDA clinical hold, exon skipping therapy
FDA delays PDUFA date for small biotech, raising questions about impact of agency cuts
United States Food and Drug Administration, PDUFA, Impact food supplement, Approved, Agencies, questions
FDA chief Makary talks expediting drug approvals, RIFs and the abortion pill
United States Food and Drug Administration, Califf, Unspecified Abortion, Contraceptives, Oral, Accelerated, Artificial Intelligence, RIFs, Infrequent, Agencies
Regeneron crumples under the weight of missed Eylea expectations
Regeneron, United States Food and Drug Administration, earnings, Eylea, decline, Sales – occupational activity
AbbVie’s Rinvoq cleared for giant cell arteritis in US
Giant Cell Arteritis, Rinvoq, upadacitinib, Approved, Janus kinase, Inhibitor, United States Food and Drug Administration, Steroids