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.
Given how the U.S. Supreme Court’s conservative majority is better known for limiting the authority of federal regulatory ...
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 ...
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 ...
Products sold in the Northwest have been given the highest risk status, but so far no illnesses have been reported.
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Trump administration pick for Health and Human Services department could cause rise in preventable disease, health expert ...
Scott Gottlieb said he’s worried that Trump’s pick to run HHS, Robert F. Kennedy Jr., will follow through on past antivaccine ...
(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 ...
Despite hotly debated biomarkers and failed or delayed confirmatory trials, the accelerated approval program has a track ...
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