FDA warns Ross Healthcare, in Lynden, WA, about CGMP violations in its production of finished drugs.
FDA accepts for review a Vanda Pharmaceuticals BLA for imsidolimab, a potential new treatment for generalized pustular psoriasis.
Fresenius Kabi recalls its Ivenix Large Volume Pump due to a software issue.
FDA grants Array BioPharma a traditional approval for its previously accelerated-approved Braftovi (encorafenib) for use in combination regimens to tr...
Novo Nordisk reports favorable weight-loss data with its triple agonist UBT251 in a Phase 2 trial in China.
FDA grants Immedica Pharma an accelerated approval for its BLA for Loargys (pegzilarginase-nbln), the first therapy specifically designed to lower pla...
FDA issues Beta Bionics a Warning Letter, citing wide-ranging quality system, complaint handling, reporting, and recall-related violations tied to the...
BioMarin decides to voluntarily withdraw from the market its Roctavian (valoctocogene roxaparvovec-rvox) gene therapy for treating adults with severe ...
