(The Center Square) - The U.S. Supreme Court, in a unanimous decision on Thursday, ruled that a cardiovascular drugmaker did ...
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 ...
Allowing the importation or reciprocal approvals of generic drugs for those with limited competition in the US could help the country better manage price spikes and shortages, researchers from Johns ...
FDA-approved carbon copies of brand-name drugs with expired patents—over the last 30 years, these generic drugs have saved ...
The Supreme Court reversed the Federal Circuit in Hikma v. Amarin, ruling that patent inducement requires active ...
In a decision that crossed the ideological divide of the nation’s highest court, all six conservative justices joined Justice ...
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 ...
This week the FDA approved the generic drug as a treatment for autism – a move that shocked health experts This week, the Trump administration announced that the FDA had approved leucovorin, a generic ...
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