Akin Gump attorneys highlight major issues in the PDUFA 8 commitment letter that is now open for public comment.
MasterControl issues its 2026 life sciences regulatory readiness playbook demonstrating the significant ways in which the FDA Quality System Managemen...
The U.S. Court of Appeals for the Fifth Circuit upholds FDAs decision to remove tirzepatide from the agencys drug shortage list, a ruling that limits ...
Reed Smith attorney James Beck says courts so far have rejected all arguments citing the Supreme Courts Loper Bright decision as a reason to reject pr...
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.
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...
