The FDA has set a PDUFA target action date of October 23, 2025, for the low-dose atropine formulation.

Insilico Medicine("Insilico"), a clinical stage generative artificial intelligence (AI)-driven biotechnology company, recently announced that its breakthrough drug candidate for idiopathic pulmonary ...

But the industry has only scratched the surface of what these drugs can do. A new range of drugs ... “CagriSema is an investigational fixed-dose combination of a long-acting amylin analogue, ...

A new drug application is anticipated for 2029. The investigational new drug application for Zabalafin Hydrogel for the treatment of mild to moderate atopic dermatitis has been cleared by the FDA ...

GSK (GSK) announced that the China National Medical Products Administration, CNMPA, has accepted for review the new drug application for the use of Nucala, a monoclonal antibody that targets ...

Zabalafin Hydrogel is a novel, first-in-class complex single-source botanical drug with multiple bioactive compounds that provide multiple mechanisms of action, including anti-pruritic (anti-itch ...

--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA ... the development and regulatory ...

Data on Lilly's muscle mass-preserving drug, bimagrumab, is due this year. Westport, Connecticut-based New England Consulting Group estimates the drugs could collectively bring in $1 billion to $5 ...

NEW YORK – Boehringer Ingelheim on Wednesday said the US Food and Drug Administration accepted its new drug application for the irreversible tyrosine kinase inhibitor zongertinib as a treatment for ...

According to Dr. Cheng, this method enables researchers to uncover new drug candidates at an unprecedented scale and speed. "The timing is crucial—we can conduct this kind of research in just a ...

The Breakthrough Therapy Designation process is intended to expedite the development and regulatory review of investigational ... including the New Drug Applications seeking FDA approval and ...