The FDA is expected to decide on treatments for Parkinson disease, PTSD and NF1-associated plexiform neurofibromas, in addition to 2 new vaccines.

The company recently announced results from two Phase 3 trials of AXS-05 for agitation. ACCORD-2, hit its main goal, but ...

Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory decisions.

This may start to bring down the cost of brand-name competitors—here's who might get access, and one major difference from ...

The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end ...

Regulators squeezed in two final approvals before the calendar change with the UK approval of Merck’s Winrevair and the FDA’s ...

Capricor Therapeutics (CAPR) announced the completion of the submission of its Biologics License Application, BLA, to the U.S. Food and Drug ...

According to Vertex Pharmaceuticals, approximately 300 additional people with CF are now eligible to receive treatment.

Capricor Therapeutics (CAPR) stock gains as the company completes the U.S. marketing application for lead drug deramiocel in ...

A collaboration between Kennedy and the New Jersey senator could be helpful for furthering nutrition policy, and could be ...

As we enter the new year, all eyes are on the biotech companies awaiting key FDA decisions in January. In 2024, the FDA approved 50 ...

GoodRx released a list of 19 of the most influential drugs and vaccines approved by the FDA in 2024 to treat a variety of ...