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Federal Register notice: FDA releases a draft guidance entitled Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic D...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...
FDA releases the form FDA-483 with three observations from an inspection at the UCB Pharma drug manufacturing facility in Braine-lAlleud, Belgium.
FDA requires updates to Boxed Warnings for prescription stimulants indicated to treat ADHD and other conditions.
Three stakeholders comment and make recommendations following an FDA listening session on methods and approaches for capturing post-approval safety an...
