By Ahmed Aboulenein WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to ...
By Padmanabhan Ananthan Feb 2 (Reuters) - Aquestive Therapeutics said on Monday the U.S. FDA has declined to approve its oral ...
By Kamal Choudhury Jan 30 (Reuters) - Shares of Corcept Therapeutics fell 16% on Friday after a corrected "complete response ...
The FDA gave the coffee recall a Class II classification, meaning consumption could cause "temporary or medically reversible ...
A year after the FDA rejected its drug for kidney dialysis patients, Unicycive Therapeutics could win approval ...
Otsuka Pharmaceutical announced that the FDA is reviewing investigational centanafadine -- a potential first-in-class ...
Annovis is also seeking fresh capital while working to advance trials for both Alzheimer's and Parkinson's disease drugs.
The FDA laid out the qualifications a site would need to qualify for PreCheck on a webpage where companies can also submit ...
“Exelixis Announces U.S. FDA Accepted the New Drug Application for Zanzalintinib in Combination with an Immune Checkpoint ...
The program will allow for frequent communication with the FDA, giving manufacturers timely input and guidance regarding the ...
FDA Commissioner Marty Makary, M.D., M.P.H., characterized the program as a “bold step” to bring manufacturing back to the US ...
Established drugs were repurposed, “me-too” drugs were approved, and even the few new biological approaches lacked clinical ...
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