On 21 October, the US Food and Drug Administration (FDA) will meet to discuss plans for the second iteration of the Generic Drug User Fee Act (GDUFA II) under which FDA says it will begin offering ...
Tentative approval covers 25 mg and 100 mg larotrectinib capsules, positioning Alembic as the first generic entrant for a ...
The US Food and Drug Administration (FDA) has approved and tentatively approved more generic drugs in FY 2018 than any other year prior, the agency announced Thursday. The 971 total includes 781 final ...
Sorensen recently reintroduced the bipartisan STOP GAMES Act, legislation aimed at preventing what he describes as "sham" ...
(The Center Square) - The U.S. Supreme Court, in a unanimous decision on Thursday, ruled that a cardiovascular drugmaker did ...
Some Canadian pharmacists are already stocking their shelves with generic versions of semaglutide, more commonly known by the brand name Ozempic. But will these generics be just as good, and how much ...
The recently enacted Consolidated Appropriations Act (H.R. 7148) includes several Food and Drug Administration (FDA) policies that were repeatedly considered in the House and Senate but were stalled ...
Prior authorization is a standard process used by insurance companies to assess the safety, cost-effectiveness, and medical necessity of certain treatments. Certain medications, especially those on ...
In legislation enacted on Feb. 3, 2026, Congress reauthorized the rare pediatric disease priority review voucher program, clarified the scope of orphan drug exclusivity (ODE) and mandated increased ...
The Supreme Court reversed the Federal Circuit in Hikma v. Amarin, ruling that patent inducement requires active ...
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