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

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 ...

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

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 ...

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

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 ...