Amgen (AMGN) Receives FDA Approval for BLINCYTO sBLA in Ph- r/r ALL
FREE Breaking News Alerts from StreetInsider.com!
StreetInsider.com Top Tickers, 4/19/2024
- Stocks end near flat as investors assess earnings, data
- Netflix Q1 earnings top estimates on blowout subscriber growth
- Taiwan Semi (TSM) Q1 profit beats expectations on AI demand
- Stocks have priced in much of the 2024 optimism - Wells Fargo
- Intuitive Surgiical (ISRG) beats earnings, revenue expectations in Q1
- Tritium DCFC Limited (DCFC): Three Australian subsidiaries were determined to be insolvent or likely to become insolvent
- Hasbro (HAS) Announces Resignation of Cynthia Williams, President of Wizards of the Coast and Hasbro Gaming
- Frontier Communications (FYBR) says third party had gained unauthorized access to portions of its information technology environment
- Ibotta (IBTA) Prices 6.56M Share IPO at $88/sh
- Netflix (NFLX) Tops Q1 EPS by 77c, Offers Guidance
- After-hours movers: Netflix, Intuitive Surgical, Nordstrom, KB Home
- Midday movers: Tesla, Blackstone, Las Vegas Sands fall; DR Horton rises
- After-hours movers: Alcoa rises; Equifax and Las Vegas Sands fall
- Midday movers: Travelers, JB Hunt fall; United Airlines rises
- After-hours movers: United Airlines, J.B. Hunt, and more
FDA Approves BLINCYTO® (blinatumomab) For Use In Pediatric Patients With Philadelphia Chromosome-Negative Relapsed Or Refractory B-cell Precursor Acute Lymphoblastic Leukemia
September 1, 2016 4:00 PM EDTTHOUSAND OAKS, Calif., Sept. 1, 2016 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) to include new data supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval, and continued approval may be contingent upon verification of clinical benefit in subsequent trials.
The approval is based on results from the Phase 1/2 '205, an open-label, multicenter, single-arm... More
