The U.S. Food and Drug Administration greenlit the classification of California-based biotechnology firm Genentech’s Venclexta (venetoclax) and azicitidine combination as a Breakthrough Therapy Drug.
Shares of Magenta Therapeutics were down after the company announced the U.S. Food and Drug Administration placed a clinical hold on its clinical program for acute myeloid leukemia and myelodysplastic syndrome.
Shares of bluebird bio climbed in trading after the company announced on March 10 that analyses demonstrate the lentiviral vector BB305 was unlikely to be the cause of acute myeloid leukemia (AML) reported in an early-stage clinical study of LentiGlobin for sickle cell disease.
The American Society of Hematology (ASH) Annual Meeting & Exposition began December 5 with numerous presentations, abstracts and posters.
The U.S. Food and Drug Administration granted Roche’s Venclexta (venetoclax) full approval in combination with azacytidine, or decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia in adults 75 years or older.
The U.S. Food and Drug Administration granted full approval of Genentech’s Venclexta (venetoclax) in combination with azacitidine, or decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
The U.S. Food and Drug Administration approved Bristol Myers Squibb’s Onureg (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission or CR with incomplete blood count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy.
Helsinn Group, based in Lugano, Switzerland, and MEI Pharma, with headquarters in San Diego, announced they were discontinuing their Phase III trial of pracinostat with azacytidine in acute myeloid leukemia (AML).
Gilead Sciences Inc. is buying Forty Seven Inc. for $95.50 per share, or a deal value of $4.9 billion. The deal was unanimously approved by both companies’ boards.
Agios Pharmaceuticals Inc. announced the U.S. FDA approved a supplemental New Drug Application to update the U.S. Prescribing Information for the isocitrate dehydrogenase-1 inhibitor Tibsovo to include adult patients with newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test who are ≥ 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.