Bristol Myers Squibb BMY and Gilead Sciences, Inc. GILD are leading biotechnology companies with broad, diverse portfolios ...
Shares of Bristol Myers Squibb BMY gained 5.62% after the company announced the continuation of the phase III ADEPT-2 study ...
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Health care professionals can have a powerful impact on labeling requirements for drugs by formally petitioning the FDA for ...
The U.S. Food and Drug Administration has approved an updated label for Unloxcyt (cosibelimab-ipdl) for the treatment of ...
Cytokinetics may be counting down the days until the FDA decides whether to approve its cardiovascular drug aficamten. But, for a biotech planning to commercialize its first drug—and without Big ...
Conditional approval extended through December 2026 for the treatment of CID in dogs CID confirmatory effectiveness trial expected to conclude in February 2026, ahead of FDA’s June deadline – 51 dogs ...
To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min The FDA has restricted the type ...
Bristol Myers Squibb BMY recently announced that it will discontinue the late-stage Librexia study on cardiovascular candidate milvexian, an investigational oral, highly selective factor XIa (FXIa) ...
Alert FDA Approves Third-Ever Drug for Lupus Nephritis Obinutuzumab (Gazyva) is the first drug to be approved for lupus nephritis since the approvals of belimumab (Benlysta) in 2020 and voclosporin ...
Alert Rejected cGvHD Therapy Gets Second Look by EMA The EMA initially rejected Rezurock due to uncertainty over its clinical benefit, noting that the pivotal study had no comparator arm and permitted ...