Federal Register notice: FDA announces that it approved Incytes Opzelura (ruxolitinib) using a rare pediatric disease priority review voucher.
CDER director Patrizia Cavazzoni tells a drug regulatory conference that FDA is considering more opportunities for sponsors to learn about inspection ...
Federal Register notice: FDA classifies endoscopic pancreatic debridement devices into Class 2 (special controls).
CBER posts an updated standard operating policy and procedure (SOPP) manual entitled SOPP 8404: Refusal to File (RTF) Procedures.
Federal Register notice: FDA classifies blood collection devices for cell-free nucleic acids into Class 2.
GSK says data from two clinical trials showed that depemokimab significantly reduces asthma exacerbations in patients with severe Type 2 inflammation.
FDA removes a partial clinical hold against Rezolutes RZ358 (ersodetug), an investigational drug for treating hypoglycemia caused by congenital hyperi...
FDA clears a Femasys 510(k) for its diagnostic device for checking the fallopian tubes to confirm permanent birth control placement.
