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FDA staffers and outside experts worry the program runs afoul of legal, ethical and scientific standards used to review new ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Illustration of New Drug Application paperwork surrounded by pills, vials, and DNA. The US Food and Drug Administration approved 46 new molecular entities in 2025. Credit: C&EN/Shutterstock The year ...

MALMÖ, SE / ACCESS Newswire / November 15, 2025 / Ascelia Pharma AB (publ) (ticker: ACE), a biotech focused on improving the life of people living with rare cancer conditions, today announced that the ...

The U.S. Food and Drug Administration is reviewing a new Parkinson's disease drug called tavapadon that could give people with the disease more control over their movements. Subscribe to our ...

The firm said at the JP Morgan Healthcare Conference that it wants zorevunersen to be approved as a disease-modifying ...