CNN says vaccine experts it interviewed are concerned that the White House will pressure FDA to approve a coronavirus vaccine before it has been adequ...
FDA identifies five companies that have recalled certain metformin extended-release products following agency testing showing levels of N-Nitrosodimet...
The Alliance for a Stronger FDA says congressional appropriations committees will be marking up bills for the FY 21 appropriations later this month an...
CDER and CBER officials tell a BIO digital conference that they are working to cope with pent-up demand and clinical trial issues in a post-Covid worl...
FDA approves Viivs Tivicay and Tivicay PD for treating pediatric patients for HIV-1.
Federal Register notice: FDA extends until 10/15 the comment period related to a draft guidance for industry #256 entitled Compounding Animal Drugs fr...
FDA approves Mylans Semglee insulin glargine product as a BLA.
IntelGenx says it learned in a 6/10 meeting with FDA officials about the CMC information that is needed in a resubmission of its Rizaport VersaFilm ND...