The FDA approved Merck’s Keytruda for the treatment of stage IB, II or IIIA non-small cell lung cancer after resection or platinum-based chemotherapy.
The companies announced today that the EU approval is indicated for treating children as young as 6 months old with severe atopic dermatitis.
The treatment is not expected to neutralize the currently dominant XBB.1.5 subvariant of Omicron.
Cannabis products, excluding Jazz Pharmaceuticals Plc’s epilepsy drug Epidiolex, are illegal at the federal level in the United States, although some states allow their use.
The FDA is working with the World Health Organization and foreign regulatory authorities to support an investigation into the source of contaminated cough syrups that have killed more than 300 children in Africa and Asia.
Datascope, a unit of Getinge, had recalled 4,454 therapeutic devices in December following a death and four serious injuries from their use.
These are the first lawsuits of their kind since the U.S. Supreme Court overturned the federal constitutional right to abortion.
The FDA’s Peripheral and Central Nervous System Drugs advisory committee will discuss the merits of Biogen and Ionis’s ALS candidate tofersen on March 22nd.
The U.S. health regulator proposed the use of one dose of the latest updated COVID-19 shot annually for healthy adults, similar to the influenza immunization campaign, as it aims to simplify the country’s current COVID-vaccine strategy.
Yesterday, Astellas announced that the FDA had lifted its clinical hold for the company’s experimental gene therapy trial for late-onset Pompe disease. The therapy was placed on clinical hold in June 2022 after a study participant experienced a severe adverse event.