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...
FDA warns San Diego, CA-based Fertility Center of California about deviations from regulations governing cells, tissues, and cellular and tissue-based...
FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) for treating patients with resectable locally advanced head and ...
FDA removes a required risk evaluation and mitigation strategies program for clozapine and its requirement to report results of absolute neutrophil co...
