Feb 3 (Reuters) - AstraZeneca said on Tuesday that the U.S. health regulator had rejected its application for an ...
The company is working with the U.S. regulator to move forward with an updated application, adding a decision is expected in ...
The program will allow for frequent communication with the FDA, giving manufacturers timely input and guidance regarding the ...
FDA officials are advising drug developers to study the long-term effects of using CAR-T in autoimmune conditions, out of ...
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 FDA issued complete response letters (CRLs) to two companies in recent days, resulting in vastly different reactions from the market. | The FDA issued complete response letters to Aquestive ...
Gold Star Distribution, Inc. recalled thousands of products, including cereals like Cheerios and Frosted Flakes.
INDIANA— Coffee drinkers in three states are being warned to double-check their morning brew. The U.S. Food and Drug ...
On January 12, NP-G2-044 (Prilukae), a novel oral fascin inhibitor earned ODD for the treatment of pancreatic cancer. This designation covers the use of the agent as monotherapy and in combination ...
Dr. Myron Czuczman highlighted the significance of the recent U.S. Food and Drug Administration (FDA) approval of Lymphir ...
An FDA-cleared wrist-worn device reliably detects convulsive seizures in epilepsy monitoring units but can miss focal ...
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