CDER Division of Applied Regulatory Science (DARS) has published its 2025 Annual Report, highlighting significant research advances, collaborative sci...
Rep. Josh Gottheimer introduces several bills to mark Rare Disease Week.
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.
