Feb 3 (Reuters) - AstraZeneca said on Tuesday the U.S. health regulator has rejected its application for a self-injectable ...
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 ...
“Exelixis Announces U.S. FDA Accepted the New Drug Application for Zanzalintinib in Combination with an Immune Checkpoint ...
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 U.S. Food and Drug Administration (FDA) has approved a drug to control seizures in dogs with idiopathic epilepsy, a type ...
IFx-2.0, an innate immune agonist, targets resistance to immune checkpoint inhibitors in advanced cutaneous melanoma, receiving FDA orphan drug designation. Phase 1 trials showed IFx-2.0's safety and ...
The FDA has granted orphan drug designation to IFx-2.0 for patients with stage 2B to stage 4 cutaneous melanoma. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the ...
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