Disease or Syndrome
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
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
Abeona’s $3.1M gene therapy wins FDA nod for rare skin disease
United States Food and Drug Administration, United States Food and Drug Administration, Infrequent, ZEVASKYN, Abeona, gene therapy, Dermatologic disorders, Hallopeau-Siemens Disease, Approved, Abeona ‘s
FDA decision on Stealth’s Barth syndrome drug delayed, again
United States Food and Drug Administration, 3-Methylglutaconic aciduria type 2, Decision, Elamipretide
FDA approves Abeonas skin disease cell therapy
ZEVASKYN, United States Food and Drug Administration, Hallopeau-Siemens Disease, Approved, Wounds – qualifier, gene therapy, Abeona, Treating
Octagon Therapeutics Ceases Operations Due to R&D Challenges and Unresolved Biology Questions
Autoimmune disease biotech, B cell immunomodulator program, OCT50 program, Novo Nordisk alliance, Winding down operations, Unresolved biology challenges
Biohaven, after setbacks, sees shares jump with Oberland Capital funding agreement worth up to $600M
Biohaven, Oberland Capital, $600 million investment, troriluzole, spinocerebellar ataxia (SCA), non-dilutive funding, FDA approval, senior secured notes