The announcement comes months after UniQure became embroiled in a public debate with FDA leaders over the clinical trial data supporting its application ... .
Seven years later, the FDA has given Colorado the go-ahead, but there's still a lot to be done ...Florida received the same FDA approval in 2024 and built a 100,000-square-foot warehouse in Lakeland to store medications after receiving them from Canada.
"FDA's announcement in adding ... For too long, the FDA's approval process prevented new sunscreen ingredients that are widely used around the world from becoming available in the United States.
The latest FDA approval was based on results from LITESPARK-022, a phase three clinical trial that took place at 285 sites around the world, including UT Southwestern ... on belzutifan’s FDA approval.
FDAFast Track Designation for its investigational therapy tazbentetol (formerly SPG302) for the treatment of Amyotrophic Lateral Sclerosis (ALS) ... FDA is expected to issue a decision by October 3, ...
Food and Drug Administration (FDA) has approved a new formulation of OMLYCLO® (omalizumab-igec), the first and only biosimilar interchangeable with XOLAIR® (omalizumab).
SKINVIVE by JUVÉDERM® is now the first and only hyaluronic acid injectable approved to reduce horizontal neck lines caused by "tech-neck.1" This is the second FDA-approved indication for SKINVIVE by ...
In February 2026, FDA Approves Difamilast (Adquey) for Atopic Dermatitis. The FDA granted approval to difamilast 1% ointment (Adquey) for the treatment of mild-to-moderate atopic dermatitis in adults and pediatric patients aged 2 years and older.