Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

The FDA has accepted Stealth BioTherapeutics’ new drug application for its ultrarare disease candidate, providing a planned decision date of Sept. 26. The timeline is surprising since the agency ...

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 ...

AbbVie is seeking a new way to fight chronic lymphocytic leukemia, or CLL, by combining its oncology drug Venclexta with another cancer-fighting drug. The North Chicago-based drugmaker has filed a ...

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. If approved, it would be ...

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

The US Food and Drug Administration (FDA) recently announced the availability of the first-ever centralized database of Complete Response Letters (CRLs) on openFDA, one of several steps taken under ...