46 new molecular entities cleared the agency’s hurdles last year, 4 fewer than in 2024 ...

Takeda and Protagonist Therapeutics have submitted a new drug application to the FDA for rusfertide for adults with ...

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 ...

Please provide your email address to receive an email when new articles are posted on . The single inhaler includes an inhaled corticosteroid, a long-acting beta-agonist and an anticholinergic. The ...

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 ...

The Prescription Drug User Fee Act target guidelines for NDA resubmissions include acknowledgment of acceptance for review ...

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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 ...

Researchers at Harvard Medical School developed a tool that uses artificial intelligence to accelerate drug discovery and development. The new technology, called PDGrapher, applies machine learning to ...

Lucy Xiaolu Wang does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond ...