Akin Gump attorneys highlight major issues in the PDUFA 8 commitment letter that is now open for public comment.
Celcuity files a supplemental NDA for Revtorpyk (gedatolisib) for treating certain patients with hormone receptor positive, human epidermal growth fac...
FDA approves Revolution Medicines Rasonque (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer.
CNBC reports that HHS plans to appoint two new FDA deputy commissioners in hopes of exerting more influence over the agency.
FDA says the Boston Scientific recall of its ENROUTE Transcarotid Neuroprotection System is Class 1.
Participants in a 4/23 FDA meeting on increasing access to nonprescription drugs see a need to improve the electronic health record capture of informa...
An oncology physician association says its members are reporting a shortage of the chemotherapy agent ifosfamide for which no direct substitute is ava...
CDRH issues an early alert to notify the public about an Abiomed action recommending that all Automated Impella Controllers be removed from where they...
