Endos Par Pharmaceutical recalls seven lots of treprostinil injection 20g/20mL due to the potential for the presence of silicone particulates in the p...
Federal Register notice: FDA seeks comments on an information collection extension entitled Data To Support Social and Behavioral Research as Used by ...
Pharmaceutical Research and Manufacturers of America urges FDA to hold more meetings on innovative clinical trial approaches to allow more discussion ...
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...
