June 2 (Reuters) - Drug developer Cingulate said on Tuesday the U.S. Food and Drug Administration declined to approve its ...
After submitting its timed-release version of a decades-old ADHD drug to the FDA nearly a year ago, Kansas City's Cingulate ...
The CRL comes after the FDA accepted the NDA for review in October 2025 and set a Prescription Drug User Fee Act target ...
June 2 (Reuters) - Cingulate said on Tuesday that the U.S. Food and Drug Administration declined to approve its drug to treat ...
Cingulate said the Food and Drug Administration flagged certain chemistry, manufacturing and controls requests in response to its application for a drug treating ADHD. The Kansas City, Kan., ...
The FDA rejected Cingulate Inc.'s ADHD medicine application over manufacturing issues. Cingulate holds nearly $30 million in ...
WASHINGTON — The Food and Drug Administration said on Monday it is revising the labeling of all extended-release stimulants used to treat attention-deficit hyperactivity disorder to include warnings ...
Kenvue, the American company that makes Tylenol, says the U.S. Food and Drug Administration should not make proposed changes to the product’s safety label to reflect research about a possible ...
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