What You Need to Know: Most individuals, depending on age, previously vaccinated with a monovalent COVID-19 vaccine who have not yet received a dose of ...
"Today's approval is an important advance in cell therapy treatment in patients with blood cancers," said Peter Marks, M.D., Ph.D., director of the FDA's C...
Otsuka Pharmaceutical Development & Commercialization, Inc., (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) announce the Joint Meeting of the Psy...
As disclosed in September 2022, Avenue received meeting minutes from the FDA regarding a Type A meeting conducted on August 9, 2022, for IV Tramadol. At th...
The FDA has also recently granted an orphan drug designation (ODD) to GIVI-MPC. Current treatments for DMD have limited therapeutic potential as unfortunat...
Merck, a leading science and technology company, today announced the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the init...
"We remain confident in mirikizumab's pivotal Phase 3 clinical data and its potential to help people with ulcerative colitis," said Patrik Jonsson, Lilly e...
Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medic...
The design goal of the ClearPoint Maestro® Brain Model is to enable highly accurate ClearPoint interventions under both MRI and CT guidance by facilit...
Pfizer Inc. (NYSE:PFE) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) fo...
The decision from the FDA Commissioner and Chief Scientist deferred to the Center for Drug Evaluation and Research (CDER) to determine next steps to implem...
Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” or “MTEM”), announced that the U.S. Food and Drug Admini...
The FDA clearance opens the door to the world's largest medical device market. With the cost effectiveness and demonstrated ability of our cardiac monitori...
Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on development of oncology, immunology, and critical care therapies, ...
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