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...
Federal Register notice: FDA determines that a Fresenius Kabi NDA for heparin sodium injection was not withdrawn for reasons of safety or effectivenes...
Germany-based Berlin Heart recalls its Excor Pediatric Ventricular Assist Device Blood Pumps due to the potential for therapy disruption.
FDA accepts for priority review a Takeda and Hutchmed NDA for fruquintinib, indicated for treating adult patients with previously treated metastatic c...
