Trump admin's FDA medical product review units remain protected from cuts, while Marty Makary awaits confirmation as ...
The FDA told staff on Monday that reviewers of medical products and inspectors of manufacturing facilities cannot take the ...
Now the Johns Hopkins University surgeon and researcher has been nominated to lead the Food and Drug Administration. The ...
The total number of FDA positions eliminated remains unclear, but the firings appear to impact centers for food, medical ...
Three U.S. senators are calling on Robert Kennedy Jr. to disclose what he and President Trump discussed with drugmakers ...
The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics,” is a game-changer for biopharmaceutical ...
Patients enroll in phase 2 oncology trials seeking access to promising new treatments, but the risk-benefit assessments and ...
The FDA approved Stoboclo and Osenvelt, denosumab biosimilars that could offer more affordable treatment options for osteoporosis and bone loss in various patient populations. Stoboclo and ...
The FDA accepted Ordspono's BLA resubmission for relapsed/refractory follicular lymphoma, with a decision due by July 30, 2025. Ordspono demonstrated an 80% overall response rate in phase 1 and 2 ...
How easy would it be to revoke US Food and Drug Administration (FDA) approvals for drugs regarded as generally safe and effective? Not very, experts said. Any attempt would require many public ...
An expert explained the importance of the FDA’s approval of Ensacove for patients with ALK-positive non-small cell lung cancer. Ensacove (ensartinib) has been approved by the Food and Drug ...