FDA releases its latest batch of Warning Letters that includes Dae Young Foods Co. and JMA Partners, Inc.
A Tufts Center for the Study of Drug Development roundtable discussion finds that innovative biologics manufacturing is cutting companies production c...
Federal Register notice: FDA seeks comments on an information collection extension for Electronic Records; Electronic Signatures OMB Control Number 09...
BioMarin Pharmaceutical agrees to sell for $125 million its Rare Pediatric Disease Priority Review Voucher it was awarded by FDA in April when it rece...
Regeneron Pharmaceuticals says two Phase 2 studies looking at adding investigational drug nesvacumab to the companys already-approved Eylea (afliberce...
Federal Register notice: FDA seeks comments on an information collection extension for Export of FDA-Regulated Products: Export Certificates OMB Contr...
Sen. Chuck Schumer (D-NY) calls on the Federal Trade Commission to examine direct-to-consumer home DNA kits to ensure genetic information is not sold ...
Federal Register notice: FDA makes available a draft guidance entitled Grandfathering Policy for Packages and Homogenous Cases of Product Without a Pr...