FDA issues Abeona Therapeutics a complete response letter on a BLA for prademagene zamikeracel (pz-cel), requesting additional information to satisfy ...
Draeger Medical recalls its Draeger Perseus A500 Anesthesia Workstation due to the potential for an unexpected shutdown while operating on battery pow...
FDA orders a Boxed Warning to highlight the serious risk of T cell malignancies following administration of BCMA-directed or CD-19-directed autologous...
FDA clears a Cochlear 510(k) to lower the patient age for its Cochlear Osia System from 12 years to five years for children with conductive hearing lo...
FDA approves Alvotech and Teva Pharmaceuticals Selarsdi (ustekinumab-aekn) injection for subcutaneous use, a biosimilar to Johnson & Johnsons Stelara....
FDA approves Takedas Entyvio (vedolizumab) subcutaneous administration for maintenance therapy in adults with moderately to severely active Crohns dis...
The Advanced Medical Technology Association says FDAs draft guidance on diversity plans for clinical trials needs to address what sponsors should do i...
Pharmaceutical Research and Manufacturers of America urges FDA to hold more meetings on innovative clinical trial approaches to allow more discussion ...
