Allogene Therapeutics receives an FDA fast track designation for its allogeneic CAR T product (ALLO-316) for treating patients with advanced or metast...
FDA issues a warning against using ACON Biotech Covid-19 tests due to false results concerns.
Venatorx Pharmaceuticals plans a fourth quarter NDA submission following positive results from its pivotal Phase 3 study evaluating cefepime-taniborba...
FDA says it will act on 8/4 on an Acadia Pharmaceuticals resubmitted sNDA for Nuplazid to treat hallucinations and delusions associated with Alzheimer...
A California federal judge approves a $3.65 million settlement between the defunct StemGenex stem cell clinic and 1,063 former clients who said they w...
Sen. Charles Grassley calls on the Federal Trade Commission to overcome a deadlocked vote and initiate a study into the business practices of pharmacy...
Federal Register notice: FDA makes available a revised draft guidance entitled Verification Systems Under the Drug Supply Chain Security Act for Certa...
FDA issued Zydus Lifesciences (formerly known as Cadila Healthcare) a three-item Form FDA-483 after recently inspecting the firms Jarod, Gujarat (Indi...