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...
Fresh on the heels of staff disruptions caused by the termination of about 1,000 probationary employees, the Trump administration issues a new memo ca...
Two Hollingsworth attorneys write in a Washington Legal Foundation post about a California federal court decision tossing state claims against an over...
FDA releases the form FDA-483 with five observations from an inspection at the Janssen vaccine manufacturing facility in Incheon, South Korea.
