The Director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) issued a ...

The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...

The rate of warnings initiated by the FDA continues to rise in the pharma and medical device industries. Knowing how to best ...

MATTB provides assistance and training through outreach to industry. A: CDER's Division of Drug Information (DDI) serves as a focal point for public inquiries regarding human drug products.

Plus: A stomach flu vaccine, the health impacts of California’s wildfires, lots of nine-figure deals for healthcare startups ...

Biotech stocks have slumped 15% since Donald Trump won his second presidency. That's because Trump comes with a lot of ...

In 2024, the Hatch-Waxman Act continued to play a critical role in the U.S. pharmaceutical landscape, driving the dynamics between ...

Pressure is mounting on the US Food and Drug Administration (FDA) to explain its decision to ignore an advisory committee's positive recommendation for the cancer vaccine Provenge. In the coming ...

A woman was forced to fork out £355 because of a sophisticated ULEZ scam. Lauren Matthews, 28, wants more people to know ...

In an attempt to address some of the deficiencies outlined above, we constructed FDAble, which, to the best of our knowledge, is the only free public search-engine ...

The price you pay for Wegovy (semaglutide) may depend on factors such as your dosage, whether you have health insurance coverage, and the pharmacy you use. Financial assistance may be available to ...

and critical care at the FDA Centre for Drug Evaluation and Research (CDER), said the approval is "a major step forward for patients." OSA results in repeated interruptions in breathing during ...