Disease or Syndrome
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
Lilly’s Q1 revenue surge overshadowed by CVS dumping Zepbound for Wegovy
Chorionic Villi Sampling, Zepbound, Eli Lilly, Wegovy, Health
HHS to require all “new vaccines” to be tested against placebo
Vaccines, HHS, placebo-controlled trials, COVID19 (disease), Testing, Placebos, Policy
Novartis bolsters renal disease pipeline with $1.7B deal for Regulus
Goldcrest, farabursen, Novartis
Immunic’s MS drug shows ‘modest’ brain volume impact, stock tumbles
Multiple Sclerosis, brain volume, Progressive, vidofludimus, calcium, Disability
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