Anglo-Swedish drumaker AstraZeneca said on Tuesday that the U.S. Food and Drug Administration has declined to approve its ...
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 ...
Orphan Drug Designation applies to approximately 50,000 Patients who predominantly suffer from severe chronic pain due ...
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 ...
Established drugs were repurposed, “me-too” drugs were approved, and even the few new biological approaches lacked clinical ...
FDA PreCheck pilot aims to speed U.S. pharma plant construction and approvals for critical medicines with earlier feedback.
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