FDA approval expands earlier use of Enhertu for metastatic breast cancer
The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with ...
The American Journal of Managed Care4h
OIG Report Seeks Better Oversight, Records for FDA’s Accelerated Approvals
Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...
Healio5h
FDA receives biologics license application for apitegromab in spinal muscular atrophy
A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its investigational, fully ...
FiercePharma6h
Pfizer's Braftovi combo on track for full approval in win for FDA's Project FrontRunner
Less than two months after an accelerated approval from the FDA, a drug combination featuring Pfizer’s Braftovi has turned in ...
BioSpace15h
What Trump’s Second Term Could Mean for PDUFA’s Future
Trump's pick for HHS secretary who endured confirmation hearings last week—has repeatedly criticized industry ties to the FDA ...