[ Price : $8.95]
FDA releases a list of 81 new and revised guidances in 12 categories that CDER plans to issue this calendar year.[ Price : $8.95]
FDA warns Ross Healthcare, in Lynden, WA, about CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA accepts for review a Vanda Pharmaceuticals BLA for imsidolimab, a potential new treatment for generalized pustular psoriasis.[ Price : $8.95]
Fresenius Kabi recalls its Ivenix Large Volume Pump due to a software issue.[ Price : $8.95]
FDA grants Array BioPharma a traditional approval for its previously accelerated-approved Braftovi (encorafenib) for use in combin...[ Price : $8.95]
Novo Nordisk reports favorable weight-loss data with its triple agonist UBT251 in a Phase 2 trial in China.[ Price : $8.95]
FDA grants Immedica Pharma an accelerated approval for its BLA for Loargys (pegzilarginase-nbln), the first therapy specifically d...[ Price : $8.95]
FDA issues Beta Bionics a Warning Letter, citing wide-ranging quality system, complaint handling, reporting, and recall-related vi...