FDA resumes posting complete response letters just days after HHS confirmed that new rejection letter releases had been halted temporarily while the a...
FDA approves a new subcutaneous formulation of Sanofi's anti-CD38 monoclonal antibody Sarclisa (isatuximab-irfc), allowing the therapy to be administe...
An FDA inspection of SGS North America's contract testing laboratory identifies significant concerns with the firms laboratory controls, including a f...
FDA has expanded the indication for Merck's Keytruda (pembrolizumab), including its subcutaneous formulation Keytruda Qlex (pembrolizumab and berahyal...
FDA grants Fast Track designation to Arialys Therapeutics ART5803 to treat anti-NMDA receptor encephalitis.
Referencing a Stat online report, MSN identifies three finalists to replace Marty Makary as FDA commissioner.
CDER and CBER continue to experience net workforce losses through the first nine months of fiscal year 2026, although hiring improved during the third...
AstraZeneca and Ionis Pharmaceuticals say that their Phase 3 CARDIO-TTRansform trial evaluating Wainua (eplontersen) in patients with transthyretin-me...
