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

Ionis Pharmaceuticals IONS announced that the FDA has granted the Breakthrough Therapy designation to its pipeline candidate, ION582, for the treatment of Angelman syndrome (AS), a rare neurological ...

The FDA approved Novo Nordisk’s once-daily Wegovy pill, making it the first oral GLP-1 weight loss drug to reach the U.S.

Merck MRK announced that the FDA has granted the Breakthrough Therapy designation (BTD) to its B7-H3-directed DXd antibody-drug conjugate (ADC), ifinatamab deruxtecan (I-DXd), for treating adult ...

AstraZeneca AZN and its Japan-based partner Daiichi Sankyo announced that the FDA has granted a Breakthrough Therapy designation (“BTD”) to their blockbuster antibody-drug conjugate (ADC), Enhertu, ...

Please provide your email address to receive an email when new articles are posted on . The FDA approved the adenoviral vector-based immunotherapy, zopapogene imadenovec-drba, for treatment of certain ...

Sevabertinib received FDA accelerated approval for nonsquamous NSCLC with HER2 TKD mutations, based on the SOHO-01 trial results. Patients naïve to HER2-targeted therapies showed a 71% ORR and a ...

Stoboclo and Osenvelt were approved as interchangeable biosimilars for bone loss conditions, potentially reducing costs and increasing access. Darzalex Faspro was approved for high-risk smoldering ...

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

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 ...