Food and Drug Administration (FDA)
NEWS
Boehringer and BiomX intend to use the discovery platform to identify biomarkers for a pathogenic bacterium thought to be associated with IBD.
Spero Therapeutics received a Complete Response Letter from the U.S. Food and Drug Administration for its complicated urinary tract infection therapy, tebipenem HBr oral tablets.
Monday morning, Nuvation Bio announced that the U.S. Food and Drug Administration placed a partial clinical hold on its Phase I dose escalation study of NUV-422.
BMS’ CAR-T therapy Breyanzi picked up a second approval from the FDA. The cancer drug was approved for the treatment of adult patients with large B-cell lymphoma.
Otsuka Pharmaceutical and Lundbeck announced positive Phase III clinical trial results Monday regarding brexpiprazole (Rexulti) as a treatment for agitation in patients with Alzheimer’s dementia.
The FDA has placed Astellas Pharma’s Phase I/II FORTIS trial on clinical hold after one of its study participants experienced a serious adverse event.
Amryt Pharma is filing a formal dispute resolution request (FDRR) with the FDA after receiving a CRL that delays the production of its drug for a rare skin disorder.
FDA releases new draft guidance that addresses Breakthrough Therapy designation and action plan for rare, neurodegenerative diseases.
Sarepta announced that the FDA has put the Phase II trial for its SRP-5051 (vesleteplirsen) for the treatment of patients with DMD on clinical hold following a serious safety signal.
JOBS
IN THE PRESS