FDA releases the form FDA-483 with seven observations from an inspection at Indias Indoco Remedies manufacturing facility for sterile and non-sterile ...
Data from an AstraZeneca interim analysis of its SERENA-6 Phase 3 breast cancer trial show that camizestrant in combination with a cyclin-dependent ki...
FDA clears a Google 510(k) for its Loss of Pulse Detection feature and its use on the Pixel Watch 3.
CDERs 10th yearly drug safety report highlights the FY 2024 establishment of two new units contributing to drug safety.
Canadian researchers find that 16% of patients in Phase 2 oncology trials receive treatments that are later approved by FDA for their condition.
FDA clears an Abanza 510(k) for its WasherCap Mini fixation system for soft tissue repair, including meniscal root repair and anterior cruciate ligame...
FDA accepts for review a Regeneron Pharmaceuticals BLA resubmission for odronextamab in relapsed/refractory follicular lymphoma.
GenBioPro, which manufactures FDA-approved generic mifepristone, says it wants to be added to the list of defendants in a suit seeking to ban the drug...
