Accelerated approval of semaglutide 7.2 mg establishes a higher-dose, once-weekly GLP-1 RA option for long-term weight ...
The FDA is continuing its quest to speed up drug approvals and make more drugs available over the counter (OTC), FDA ...
A stronger 7.2 mg dose of Wegovy wins FDA approval after a 54-day review, promising greater weight loss for eligible patients ...
The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...
Orforglipron is the first new molecular entity cleared under the FDA's Commissioner's National Priority Voucher (CNPV) pilot ...
A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...
The FDA’s decision is based on data from the ONWARDS Phase IIIa clinical programme involving nearly 2,680 adults.
FDA has delayed the effective dates for beetroot red and spirulina extract color additives after GMO/Toxin Free USA and ...