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 Padmanabhan Ananthan Feb 2 (Reuters) - Aquestive Therapeutics said on Monday the U.S. FDA has declined to approve its oral ...
By Ahmed Aboulenein WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to ...
The FDA laid out the qualifications a site would need to qualify for PreCheck on a webpage where companies can also submit ...
GTB-5550 Phase 1 dose escalation basket trial expected to initiate mid-2026 Phase 1 protocol allows multiple solid tumor ...
Market launch for its first of a kind integrated patient warming and securement system planned for third quarter of this yearNOVI, Mich., Feb. 03, 2026 (GLOBE NEWSWIRE) -- Gentherm (NASDAQ: THRM) a ...
The FDA Center for Drug Evaluation and Research has accepted a letter of intent for the first biomarker for idiopathic pulmonary fibrosis into its Biomarker Qualification Program, according to a press ...
The company is working with the U.S. regulator to move forward with an updated application, adding a decision is expected in ...
“Exelixis Announces U.S. FDA Accepted the New Drug Application for Zanzalintinib in Combination with an Immune Checkpoint ...
THE Food and Drug Administration (FDA) warned the public against the presence of a counterfeit version of an anti-rabies ...
The Food and Drugs Authority (FDA) has ordered the immediate closure of all food service establishments across the country ...
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