Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...

Previous policy allowed up to a 12-month delay before articles were required to be made available to the public for free ...

While China’s regulatory process doesn’t uphold the patient safeguards that Americans rightly insist upon, the U.S. FDA could still streamline its path into early-stage drug development ...

C-Path quickly emerged as a pioneer in accelerating drug development by launching landmark consortia and earning early regulatory endorsements for innovative safety kidney biomarkers by FDA ...

FDA schedules End of Phase 2 meeting with Adial to discuss Phase 3 plans for AD04, its genetically targeted drug for Alcohol ...

NCP is a condition that causes severe pain and sensitivity of the eyes, face, or head. The exact cause is unknown but is ...

A vocal opponent of his predecessor Peter Marks, Vinay Prasad will now lead the office tasked with reviewing some genetic ...

Orchestra BioMed (Nasdaq:OBIO) announced that it received FDA investigational device exemption (IDE) for its Virtue ...

The U.S. Food and Drug Administration ... the path for companies to build new production sites as potential tariffs on imported medicines loom. The order directs the FDA to reduce the amount ...

ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced that the Company received a Refusal to ...