FDA sends ITM Isotope Technologies Munich SE a Complete Response Letter (CRL) for its investigational radiopharmaceutical for gastroenteropancreatic n...
Abiomed and manufacturing partner Oscor issue a correction (Class 1 recall) for certain catheter introducers used with Impella heart pumps after ident...
FDA appoints Sarah Ibrahim as CDER deputy center director for Regulatory Programs, a role she has been serving in an acting capacity since January.
FDA's announces a 9/23 advisory committee meeting to vote on a Grail PMA for the Galleri test and its use in the early detection of multiple cancers.
Primus petitions FDA to address substantive issues about generic forms of its Impoyz psoriasis drug that were first raised by Encore Dermatology when ...
FDA cites Emcure Pharmaceuticals' sterile injectable manufacturing facility in Ahmedabad, India, for multiple GMP deficiencies following an inspection...
The Trump administration considers an executive order addressing vaccines and autism as soon as next week.
Senators Jim Banks (R-IN) ) and Cory Booker (D-NJ) introduce the bipartisan Prescription Information Modernization Act to allow drug makers to distrib...
