US Supreme Court to scrutinize FDA denial of flavored vape products
The U.S. Supreme Court is set on Monday to hear the U.S. Food and Drug Administration's defense of the agency's refusal to let two e-cigarette companies sell flavored vape products that regulators found to pose a significant health risk to youths.
Trump, RFK Jr and FDA Commissioner
Reaffirms New Drug Application (NDA) first quarter 2025 submission guidanceConfirms no additional adult clinical trials are necessary prior to NDA submission Commenced pediatric trial in the U.S. and ...
Given how the U.S. Supreme Court’s conservative majority is better known for limiting the authority of federal regulatory ...
The FDA has rejected Applied Therapeutics’ attempt to win approval on the strength of a failed phase 3 trial, triggering a 75% drop in the biotech’s share price. Applied said the complete response ...
(RTTNews) - Cytokinetics (CYTK) announced the FDA has accepted the companys New Drug Application for aficamten for the treatment of obstructive hypertrophic cardiomyopathy. The FDA assigned the ...
Products sold in the Northwest have been given the highest risk status, but so far no illnesses have been reported.
SOUTH SAN FRANCISCO, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that ...
Despite hotly debated biomarkers and failed or delayed confirmatory trials, the accelerated approval program has a track ...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
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