Merck reports that its Phase 3 TroFuse-005 trial evaluating the investigational antibody-drug conjugate sacituzumab tirumotecan met its primary endpoints in certain patients with advanced or recurrent endometrial cancer.
A legal analysis reviews how an FDA guidance issued last year is reshaping how pharmaceutical and medical device companies can communicate scientific information about off-label uses of approved products, while it also creates new compliance challenges for industry.
Merck reports that its Phase 3 TroFuse-005 trial evaluating the investigational antibody-drug conjugate sacituzumab tirumotecan met its primary endpoints in certain patients with advanced or recurrent endometrial cancer.
A legal analysis reviews how an FDA guidance issued last year is reshaping how pharmaceutical and medical device companies can communicate scientific information about off-label uses of approved products, while it also creates new compliance challenges for industry.
DTC Perspectives CEO Bob Ehrlich says the sudden departure of former FDA commissioner Marty Makary is unlikely to result in major changes to the agency’s approach toward direct-to-consumer pharmaceutical advertising.
FDA replaces the acting leaders of CDER and CBER following the resignation of former commissioner Marty Makary.
