The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...
The Food and Drug Administration (FDA) announced on Thursday that it authorized the marketing of Zyn nicotine pouches but ...
The FDA is reviewing new vaccines for meningitis and chikungunya and therapies for Parkinson disease and PTSD.
A review of the FDA’s drug approvals of 2024 shows that small companies loomed large—both in the sheer number of nods g | ...
The Bruton tyrosine kinase inhibitor was approved in combination with bendamustine and rituximab in previously untreated ...
The U.S. Food and Drug Administration has approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to sever ...
The U.S. Food and Drug Administration (FDA) has approved 20 ZYN nicotine "pouch" products for sale after what it called "a ...
The U.S. Food and Drug Administration on Thursday okayed the marketing of 20 Zyn nicotine pouch products after undertaking an ...
The Biden administration announced Friday that Ozempic, Wegovy and 13 additional drugs will now be covered under Medicare ...
The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional ...