Applied Therapeutics says it received FDA's warning letter for genetic disease drug study
Applied Therapeutics said on Monday it received a warning letter limited to a trial studying its genetic disease drug, after ...
Supreme Court weighs FDA’s power to prohibit new vaping products for teens
Supreme Court hears arguments over the power of the Food and Drug Administration to prohibit the sale of candy-colored vaping ...
Biotech Stocks Facing FDA Decision In December 2024
The FDA has approved 43 novel drugs so far this year (January-November), compared to 52 during the same period last year. As we step ...
BioPharma Dive11h
Novocure device succeeds in pancreatic cancer study; FDA sets Cytokinetics decision date
Using tumor-treating fields alongside chemotherapy improved patient survival, Novocure said. Elsewhere, Cytokinetics got a ...
Cytokinetics Announces FDA Acceptance of New Drug Application for Aficamten for the Treatment of Obstructive Hypertrophic Cardiomyopathy
PDUFA Target Action Date Set for September 26, 2025SOUTH SAN FRANCISCO, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated ...