[ Price : $8.95]
After receiving a 2019 complete response letter, Lexicon Pharmaceuticals resubmits its NDA for sotagliflozin oral tablets as an ad...[ Price : $8.95]
CBER director Peter Marks again overrides his Centers review teams in approving a supplemental BLA that expands the approval and c...[ Price : $8.95]
Zoll Medical recalls (Class 1) its Zoll 731 Ventilators and their operator and quick reference guides.[ Price : $8.95]
FDA lifts a partial clinical hold on PTC Therapeutics PTC518 for treating Huntingtons disease based on the agencys review of Phase...[ Price : $8.95]
FDA approves changes to the REMS for Kites lymphoma treatments Yescarta and Tecartus.[ Price : $8.95]
FDA releases the form FDA-483 issued with four observations following an inspection at the Dr. Reddys active pharmaceutical ingred...[ Price : $8.95]
FDA publishes a guidance describing the behaviors the agency sees as delaying, denying, limiting, or refusing a drug or device ins...[ Price : $8.95]
FDA issues a draft guidance indicating that it is moving away from recommending switching studies to support an interchangeability...