Pfizer says its hemophilia drug marstacimab met the primary endpoints in the Phase 3 BASIS trial.
CDERs Office of New Drugs denies an Akebia Therapeutics dispute resolution request following receipt of a 3/22 complete response letter for vadadustat...
Two stakeholders make recommendations for improving an FDA draft guidance on clinical trial considerations to support accelerated approval of oncology...
FDA sends iRhythm Technologies a Warning Letter that cites violations from an 8/22 agency inspection of the companys Zio heart monitor manufacturing s...
Federal Register notice: FDA releases a draft guidance entitled Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic D...
Federal Register notice: FDA makes available a final guidance entitled Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological...
Bristol Myers Squibb says its Breyanzi showed positive results in a Phase 1/2 trial in patients with relapsed or refractory chronic lymphocytic leukem...
AstraZeneca says the Phase 3 DUO-E trial showed significant progression-free survival of endometrial cancer with its Imfinzi plus chemotherapy followe...
