Feb 3 (Reuters) - AstraZeneca said on Tuesday the U.S. health regulator has rejected its application for a self-injectable ...
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 ...
The FDA laid out the qualifications a site would need to qualify for PreCheck on a webpage where companies can also submit ...
The company is working with the U.S. regulator to move forward with an updated application, adding a decision is expected in ...
THE Food and Drug Administration (FDA) warned the public against the presence of a counterfeit version of an anti-rabies ...
Investing.com -- AstraZeneca PLC (ST:AZN) stock fell 1.5% in Tuesday morning trade after the U.S. Food and Drug ...
“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 ...
Established drugs were repurposed, “me-too” drugs were approved, and even the few new biological approaches lacked clinical ...
Generic medications are not the same as brand medications. Small differences in ingredients that are permitted by the FDA may ...
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