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FDA grants Bayer a priority review for its supplemental NDA for Hyrnuo (sevabertinib) as a first-line treatment for patients with ...[ Price : $8.95]
In an opern letter to president Trump, rare disease advocates urge him to push FDA to accelerate approvals for treatments targetin...[ Price : $8.95]
Regeneron Pharmaceuticals says its Phase 3 trial evaluating the experimental immunotherapy combination of fianlimab and cemiplimab...[ Price : $8.95]
Merck reports that its Phase 3 TroFuse-005 trial evaluating the investigational antibody-drug conjugate sacituzumab tirumotecan me...[ Price : $8.95]
A legal analysis reviews how an FDA guidance issued last year is reshaping how pharmaceutical and medical device companies can com...[ Price : $8.95]
DTC Perspectives CEO Bob Ehrlich says the sudden departure of former FDA commissioner Marty Makary is unlikely to result in major ...[ Price : $8.95]
Two prominent drug-policy scholars sharply criticize former FDA commissioner Marty Makary in a Health Affairs commentary, arguing ...[ Price : $8.95]
FDA replaces the acting leaders of CDER and CBER following the resignation of former commissioner Marty Makary.