FDA grants Bayer a priority review for its supplemental NDA for Hyrnuo (sevabertinib) as a first-line treatment for patients with HER2-mutant non-smal...
In an opern letter to president Trump, rare disease advocates urge him to push FDA to accelerate approvals for treatments targeting fatal genetic diso...
Regeneron Pharmaceuticals says its Phase 3 trial evaluating the experimental immunotherapy combination of fianlimab and cemiplimab in advanced melanom...
Merck reports that its Phase 3 TroFuse-005 trial evaluating the investigational antibody-drug conjugate sacituzumab tirumotecan met its primary endpoi...
A legal analysis reviews how an FDA guidance issued last year is reshaping how pharmaceutical and medical device companies can communicate scientific ...
DTC Perspectives CEO Bob Ehrlich says the sudden departure of former FDA commissioner Marty Makary is unlikely to result in major changes to the agenc...
Two prominent drug-policy scholars sharply criticize former FDA commissioner Marty Makary in a Health Affairs commentary, arguing that his tenure weak...
FDA replaces the acting leaders of CDER and CBER following the resignation of former commissioner Marty Makary.
