FDA releases a list of 81 new and revised guidances in 12 categories that CDER plans to issue this calendar year.
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...
