FDA approves Spravato as monotherapy for adults with major depressive disorder
The FDA has approved a supplemental new drug application for Spravato, an esketamine nasal spray that can be used as monotherapy for adults with treatment-resistant depression, Johnson & Johnson announced in a press release.
The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a ...
Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications. The biotechnology company said the FDA put a hold on its ...
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...
In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, the Federal Circuit jumped on the bandwagon ...
Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose regimen of nusinersen to advance the treatment of SMA CAMBRIDGE, Mass., Jan. 2 ...
The application was refiled following a December 20, 2024, meeting between the US Food and Drug Administration and Astellas.
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...
Shionogi will receive $375 million to develop a long-acting protease inhibitor designed to prevent SARS-CoV-2 infection in ...
A University of Oklahoma professor and his team have discovered a new way to put atoms into drug molecules that could revolutionize the drug industry. The safer, cheaper, more environmentally friendly ...
A couple of University of Nebraska professors have launched a startup company with the goal of bringing to market an ...
CAMBRIDGE, Mass. & SALISBURY, England - KalVista Pharmaceuticals, Inc. (NASDAQ: NASDAQ:KALV) has received Orphan Drug ...
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