Disease or Syndrome
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
Novartis to buy Regulus Therapeutics for up to $1.7B
Goldcrest, Novartis, Acquisition (action), Kidney Diseases
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
Novo Nordisk taps telehealth giants to distribute Wegovy, sending shares soaring
Wegovy, Nordisk, LifeMD, Telemedicine, Access, CALR gene, Obesity, semaglutide, Adult