Disc is seeking accelerated approval and priority review of its NDA submission FDA decision to accept and file the NDA for review occurs within 60 days of submission WATERTOWN, Mass., Sept. 30, 2025 ...
The Prescription Drug User Fee Act target guidelines for NDA resubmissions include acknowledgment of acceptance for review ...
The FDA is expected to decide on treatments for breast cancer, EBV+ post-transplant lymphoproliferative disease, focal segmental glomerulosclerosis, presbyopia, and severe allergic reactions.
The FDA's complete response letter for Dasynoc was due to manufacturing issues, delaying its approval for chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) treatment. Dasynoc, a ...
Cytokinetics, Incorporated announced that the FDA has extended the action date for aficamten, a treatment for obstructive hypertrophic cardiomyopathy (oHCM), to December 26, 2025. The extension is due ...
James V. Caruso, President and CEO, stated that Cellectar has made "significant strides across our development pipeline, regulatory strategy, corporate development initiatives and fundraising efforts, ...
The Chosun Ilbo on MSN
Oral obesity drugs near FDA approval, domestic launch planned
New obesity treatments such as 'oral Mounjaro' and 'high-dose Wegovy' are scheduled to be released next year. The U.S. Food and Drug Administration (FDA) review of Danish pharmaceutical company Novo ...
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 ...
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