FDA approves a Sun Pharmaceutical Industries NDA for Ilumya (tildrakizumab-asmn) for treating adults with moderate-to-severe plaque psoriasis who are ...
Federal Register notice: FDA makes available a draft guidance entitled Postmarketing Safety Reporting for Combination Products.
Federal Register notice: FDA makes available an immediately in effect guidance entitled Compliance Policy for Combination Product Postmarketing Safety...
FDA approves an expanded indication for Seattle Genetics Adcetris to treat adults with previously untreated stage 3 or 4 classical Hodgkin lymphoma in...
Three FDA executives say the agency is increasing staff and technology to intercept packages containing illegal products with hidden drug substances c...
FDA approves a Teligent ANDA for halobetasol propionate ointment, 0.05%, indicated for treating a variety of skin conditions.
FDA grants Fennec Pharmaceuticals a fast track designation for Pedmark (sodium thiosulfate) for preventing cisplatin-related ototoxicity in pediatric ...
Researchers say that pivotal trials based on non-continuous surrogate markers often exaggerate treatment effects.