The FDA approved a once-weekly, long-acting basal insulin for adults with type 2 diabetes as an alternative to daily basal ...

It’s the first such meeting since Robert F. Kennedy Jr. became the nation’s top health official last year. Kennedy has vowed ...

Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic ...

The guidance clarifies what sponsors should consider when putting together an application for the validation of a NAM ...

Hims & Hers Health, Inc. (NYSE: HIMS) today announced that a broad assortment of Novo Nordisk’s FDA-approved GLP-1 medications are available to eligible customers, including the Wegovy® pill, which is ...

As part of an investigation that dates back to 2023, the FDA has identified over two dozen products featuring the plant.

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...

Ilumya has secured marketing authorisations from more than 55 health authorities worldwide.

For the first time, Americans with depression will soon be able to use a prescription brain-stimulation device at home. The approval comes from the U.S. Food and Drug Administration and marks a major ...

The U.S. Food and Drug Administration (FDA) refused to consider Moderna’s application for a new flu vaccine using mRNA technology, the company announced Tuesday, a decision that could delay the ...

Upon approval, Rocket has been awarded a priority review voucher, which currently fetch around $200m on the secondary market.

A Food and Drug Administration (FDA) memo has reported that the COVID-19 vaccine contributed to the deaths of at least 10 children. Following the release of the Friday memo, which was obtained by ...