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U.S. FDA Accepts for Priority Review Supplemental Biologics License Application and EMA Validates Application for Reblozyl® (luspatercept-aamt) as First-Line Treatment of Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS)

Applications based on results from Phase 3 COMMANDS study in which first-in-class Reblozyl demonstrated a highly statistically significant and clinically meaningful improvement compared to an... | May 1, 2023
Origar Beta Noah Berkowitz Maedica Bucur Bristol Myers Squibb Acceleron Pharma Inc European Medicines Agency

U.S. FDA Accepts for Priority Review Supplemental Biologics License Application and EMA Validates Ap

Applications based on results from Phase 3 COMMANDS study in which first-in-class Reblozyl demonstrated a highly statistically significant and clinically meaningful improvement compared to an erythropoiesis-stimulating agent in patients with very low/low/intermediate-risk MDSU.S. FDA has assigned a target action dat...
Bristol Myers Squibb Origar Beta Noah Berkowitz Maedica Bucur European Medicines Agency Hematology Development

FDA Grants Priority Review to Luspatercept for First-line Treatment of Anemia in Lower-risk MDS

The FDA has granted a priority review to the supplemental biologics license application seeking to expand the current indication of luspatercep to include treatment of anemia in patients with very low- to intermediate-risk myelodysplastic syndrome who have not previously received erythropoiesis-stimulating agents and who may require red blood cell transfusions.
Noah Berkowitz World Health Organization Bristol Myers Squibb Hematology Development European Medicines Agency Prescription Drug User Fee

Bristol Myers Squibb Receives European Commission Approval of Reblozyl (luspatercept) for Anemia in Adult Patients with Non-Transfusion-Dependent Beta Thalassemia

Third authorized indication in Europe for Reblozyl, a first-in-class treatment for patients with diseases impacted by anemia Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission
United Kingdom United States Dennis Riedl Origar Beta Noah Berkowitz Bristol Myers Squibb

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Investegate |NOVARTIS AG CHF0.50(REGD) Announcements | NOVARTIS AG CHF0.50(REGD): Novartis highlights scientific advances with Kisqali, iptacopan, Scemblix and YTB323 data at SABCS and ASH

Investegate announcements from NOVARTIS AG CHF0.50(REGD), Novartis highlights scientific advances with Kisqali, iptacopan, Scemblix and YTB323 data at SABCS and ASH
United States Richard Jarvis Isabella Zinck Jeff Legos Michael Meo Satoshi Sugimoto

Novartis provides update on Phase III CANOPY-A study evaluating canakinumab as adjuvant treatment in non-small cell lung cancer

15.08.2022 -  Phase III CANOPY-A trial did not meet primary endpoint of disease-free survival in patients with stages II-IIIA and IIIB completely resected non-small cell lung cancer1Findings will be presented at an upcoming medical meetingNovartis remains ... Seite 1
United States Jeff Legos Global Head Of Oncology Hematology Development American Joint Committee On Cancer Union For International Cancer Control Executive Vice President

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