Eli Lilly announced that its experimental weight-loss pill, orforglipron, meets most of the criteria for the U.S. Food and ...
The FDA’s new Commissioner’s National Priority Voucher signals a transformative shift in U.S. drug review, tying accelerated approval to manufacturing readiness, domestic supply-chain strength, and ...
The FDA has named six new additions to the Commissioner’s National Priority Voucher (CNPV) program, expanding the initiative to 15 products that address critical public health and national security ...
Linvoseltamab and sunvozertinib received FDA approval for multiple myeloma and non-small cell lung cancer, respectively, based on robust clinical trial data. Sebetralstat offers a new oral on-demand ...
The Food and Drug Administration (FDA) has issued new draft guidance signaling a policy shift toward reducing the need for comparative efficacy ...
While the agency granted full approval to Nuvaxovid for use in older adults aged 65 and above, it restricted the vaccine’s use in individuals aged 12-64 with at least one underlying condition that ...
Envoy Medical Inc. (NASDAQ:COCH) announced on Tuesday that it has received U.S. Food and Drug Administration (FDA) approval to expand its pivotal clinical trial for the fully implanted Acclaim ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback