FDA posts a five-item FDA Form-483 after inspecting Covid-19 vaccine maker Serum Institute of Indias Maharashtra manufacturing facility.
Rocket Pharmaceuticals withdraws its BLA for RP-L102 (mozafancogene autotemcel), an investigational gene therapy for treating Fanconi Anemia.
Amgen says its Repatha met the primary endpoints in a landmark Phase 3 trial, making it the only PCSK9 inhibitor to demonstrate a significant reductio...
FDA posts a four-item Form FDA 483 that was issued to Laboratorios Grifols after a 7/2024 inspection of the firms drug manufacturing facility in Barce...
FDA accepts for review a Daiichi Sankyo and AstraZeneca supplemental BLA for Enhertu use followed by paclitaxel, trastuzumab, and pertuzumab as a neoa...
FDA approves Jazz Pharmaceuticals Zepzelca (lurbinectedin) in combination with Genentechs Tecentriq or Tecentriq Hybreza for the maintenance treatment...
FDA commissioner Martin Makary says on a CNN podcast that changes should soon be announced to a Boxed Warning on some hormone replacement therapy prod...
FDA grants Bristol Myers Squibb fast-track status for its investigational Alzheimers therapy BMS-986446.
