The revision of labeling for products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug referenced in the ANDA.

Researchers from the National University of Singapore (NUS) have pioneered a new catalytic transformation that converts ...

The investigational new drug application for Zabalafin Hydrogel for the treatment of mild to moderate atopic dermatitis has ...

The Breakthrough Therapy Designation process is intended to expedite ... related filing and approval timelines, including the New Drug Applications seeking FDA approval and the MAA and EU-M4all ...

The Pre-Investigational New Drug Application (IND) Consultation Program fosters early ... needed for the IRB and/or FDA to make a determination. Learn more on the FDA process Here is where differences ...

PharmaTher Holdings (CSE:PHRM) is on track to resubmit information to the U.S. Food and Drug Administration (FDA) by the end ...

Gilead pharmaceutical company announced today (Tuesday, Feb. 18) that the U.S. Food and Drug Administration has accepted the ...

The FDA has accepted an investigational new drug application for ALLO-329, an allogeneic chimeric antigen receptor T-cell ...

GSK (GSK) announced that the China National Medical Products Administration, CNMPA, has accepted for review the new drug application for the ...

In September of 2023 Vanda submitted a New Drug Application (NDA) seeking approval by the FDA. In September of 2024 the FDA rejected the application via a Complete Response Letter, suggesting that ...

February 18, 2025--(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) submissions fo ...