The FDA has approved Liraglutide Injection, the first generic version of Victoza, for the treatment of type 2 diabetes.
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DNLI's Hunter Syndrome Drug Gets Breakthrough Therapy DesignationDenali Therapeutics Inc. DNLI announced that the FDA has granted Breakthrough Therapy Designation to its pipeline candidate, ...
The US FDA approved the first generic referencing Victoza, a GLP-1 receptor agonist indicated to improve glycemic control.
Johnson & Johnson has won Food and Drug Administration priority review for its application seeking approval of nipocalimab in certain patients with generalized myasthenia gravis.
Dr. Eric K. Singhi discusses the benefit of subcutaneous immunotherapy following the FDA approval of subcutaneous Opdivo for ...
The US Food and Drug Administration approved 50 new molecular entities in 2024 —just five fewer than it did in 2023. Last ...
The FDA has approved Opdivo Qvantig (nivolumab and hyaluronidase-nvhy), a new subcutaneous injection formulation of Opdivo.
Nivolumab biosimilar is under clinical development by Amgen and currently in Phase III for Metastatic Melanoma.
The FDA approved subcutaneous nivolumab for solid tumors, tiselizumab for advanced gastric and GEJ cancers, and key 2024 breast cancer breakthroughs are reviewed. Experts provide perspective on ...
The U.S. Food and Drug Administration has approved Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) injection for ...
On December 20, 2024, the FDA granted accelerated approval to the combination of encorafenib (Braftovi), cetuximab (Erbitux), ...
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