Bristol Myers Squibb (NYSE:BMY) today announced that additional data from multiple studies evaluating
Zeposia (ozanimod) in ulcerative colitis (UC) were presented at Digestive Disease Week ® (DDW), taking place virtually May 21-23, 2021. These data deepen the understanding of
Zeposia and reinforce Bristol Myers Squibbâs commitment to understanding and addressing unmet needs in gastroenterology.
Research being shared includes:
Safety of Ozanimod in Patients with Moderately to Severely Active Ulcerative Colitis Over Time: Pooled Analysis from Phase 2, Phase 3, and Open-Label Extension Trials
Pooled analysis including data from the Phase 2 TOUCHSTONE study, Phase 3 True North study and open-label extension trial. Long-term treatment with
- Bylvay has the potential to become first approved drug to treat all forms of PFIC - - CHMP opinion is based on the PEDFIC Phase 3 studies - - PEDFIC 1 met the bile acid (P=0.003) and pruritus
Marks: Yankees breakthrough Covid cases not shocking politico.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from politico.com Daily Mail and Mail on Sunday newspapers.
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NEW YORK, May 19, 2021 /PRNewswire/
WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Kadmon Holdings, Inc. (NASDAQ: KDMN) between October 1, 2020 and March 10, 2021, inclusive (the Class Period ) of the important June 2, 2021 lead plaintiff deadline.
SO WHAT: If you purchased Kadmon securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.
WHAT TO DO NEXT: To join the Kadmon class action, go to http://www.rosenlegal.com/cases-register-2073.html or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] or [email protected] for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court
Interim Report Q1, 2021
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Filing of New Drug Application submission to the FDA Following the positive top line readout of our pivotal Phase 3 trial NefIgArd, which met both the primary and key secondary endpoints with results being statistically significant and clinically relevant we commenced the regulatory filing process which ultimately resulted in the timely filing of the submission to the FDA in Q1 as planned. In April, we received the response from the Food and Drug Administration (FDA) who accepted the submission and granted Priority Review for the New Drug Application (NDA) for Nefecon. The FDA have set a Prescription Drug User Fee Act (PDUFA) goal date of September 15, 2021. During Q1, we also submitted a request for accelerated assessment to the EMA, which was granted on April 23rd. These grants reflect the perceived unmet medical need in IgAN by regulators and, in my view, also the strength and overall quality of our dossier.