The initiative is a response to a Trump administration order to speed the construction of the type of new drug factories many ...

First Patient Dosing Expected in Q1 2026 • Clinical Trial to Prioritize Biomarker-Selected RBM39-Dependent Cancers KING OF ...

MAXONA Pharmaceuticals today announced that the company has submitted an Investigational New Drug (IND) Application to the ...

Alzinova AB (publ) (Nasdaq First North: ALZ) today announced that the company has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for the planned P ...

A new pill that combats antibiotic-resistant strains of gonorrhoea is closer to US approval, after the FDA accepted GSK’s gepotidacin for priority review.

The new initiative, FDA PreCheck, was developed in response to President Donald Trump’s executive order to accelerate the ...

The Food and Drug Administration Aug. 7 announced a new program to help improve the domestic pharmaceutical supply chain by ...

The agency’s new program is designed to increase regulatory predictability and streamline review of domestic manufacturing ...

The FDA approved an investigational new drug application for ABT-301, clearing the way for a new clinical trial in metastatic ...

According to the FDA, Amphastar's iron sucrose injection meets the criteria for bioequivalence and therapeutic equivalence to Venofer® for the treatment of iron deficiency anemia in patients with chro ...

British drugmaker GSK said on Monday its supplemental new drug application for antibiotic drug gepotidacin has been accepted for priority review by the U.S. Food and Drug Administration for the oral ...

Obstructive sleep apnea severity measured via apnea-hypopnea index decreased among patients receiving AD109, an oral ...