The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

The joint guidance was created to ensure drug developers employ best practices when using AI.

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...

The FDA has granted breakthrough therapy designation to Novartis’ ianalumab for Sjögren’s disease, according to a press release from the manufacturer.In its statement, Novartis said it plans to submit ...

The U.S. Food and Drug Administration will award up to $50 million over five years to the University of North Carolina at Chapel Hill and Duke University to establish the Research Triangle Center of ...

The U.S. Food and Drug Administration on Thursday introduced the Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability in the review of therapies intended to treat rare ...

The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...

Speaking at the 2026 J.P. Morgan Healthcare Conference, Hogan Lovells global regulatory partners Elizabeth Jungman and Brian ...

The collaboration marks a turning point in AI-driven drug design and trial forecasting, de-risking the drug development ...

PharmTech spoke with Dr. Asma Patel, VP Global Commercial and Scientific Consulting–Drug Product, to find out how the growth ...

In Darwinian terms, survival isn’t a matter of being the biggest, the fastest, or the strongest of the species, but instead ...

Insilico Medicine (3696.HK), a clinical-stage drug discovery and development company driven by generative artificial ...