(Reuters) -Federal regulators have asked Novavax to complete an additional clinical trial on its COVID-19 vaccine after ...

A new randomized study could cost Novavax tens of millions of dollars, vaccine experts say ...

The tech giant’s Damo Academy secured a “breakthrough device” designation from the US regulator for its pancreatic ...

The bone graft incorporating rhBMP-2 has received FDA IDE approval for a pivotal clinical trial in spinal fusion ...

In the fifth episode of a six-part interview series on immunotherapy, Marc Voigt, CEO and Executive Director of Immutep ...

New drug review processes would be accelerated and completed in 120 days in response to a US plan to raise pharmaceutical tariffs, the Ministry of Health and Welfare said yesterday. Food and Drug ...

The U.S. has not seen the approval of a new sunscreen ingredient since the 1990s. The FDA ... drugs, which could have implications for the approval of new sunscreen ingredients in the United States.

On a recent call with analysts at BMO Capital Markets, a “former director” at the FDA’s Center for Biologics Evaluation and ...

The US FDA has granted approval for the use of Medtronic’s disposable Simplera Sync sensor with the MiniMed 780G system.

Treatments for COPD, psoriasis, and neuroendocrine tumors, as well as a next-generation COVID-19 vaccine are under review.

Following massive layoffs and cuts at the FDA, Makary’s plan for the agency is yet to fully unfold. But he has hinted at what ...