FDA sets 1/29/23 as the PDUFA action date for a Pfizer/Myovant sNDA to update the labeling of Myfembree.
Atrium Medical recalls its iCast Covered Stent System after receiving increased customer complaints about the balloon or catheter hub separating from ...
Three doctors sue FDA over the agencys efforts to prevent the use of ivermectin to treat Covid-19.
FDA says it has pulled its approval of TG Therapeutics Ukoniq for two lymphoma indications due to safety concerns.
FDA launches a Web page, required by the 21st Century Cures Act, on antibacterial and antifungal susceptibility test interpretive criteria.
FDA grants breakthrough therapy designation to Sanofis efanesoctocog alfa to treat hemophilia A.
Researchers say CMS too often pays for drugs that received FDA accelerated approval but did not confirm a clinical benefit.
FDA removes a clinical hold against a Legend Biotech Phase 1 clinical trial of LB1901, an investigational autologous chimeric antigen receptor T-cell ...