The US FDA has appointed George Francis Tidmarsh, MD, PhD, as director of the Center for Drug Evaluation and Research.

The recall of more than 160,000 bottles of levothyroxine sodium, which went into effect June 20, was upgraded to a Class II recall on July 23. Class II recalls occur when use of the drug poses a ...

European regulators on Friday said that the Duchenne muscular dystrophy gene therapy Elevidys should not be approved ...

There was a lot of excitement when Tepezza became the first drug approved for the treatment of thyroid eye disease in January ...

In recently reported case studies, nemolizumab, approved for two indications associated with itch, has been reported to be ...

In 2024, studies suggested that lenacapavir, already used to treat people with HIV, was nearly 100% effective in stopping ...

Once the regulator's guidance is accepted by the European Commission, the authorisation is valid in all 27 EU member countries as well as Iceland, Norway and Liechtenstein.

The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...

Regulatory consultant’Rourke argues why the EU's current novel food regulation is slow, and what it can learn from ...