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.

The U.S. Food and Drug Administration green-lit a new treatment for acute myeloid leukemia (AML) for patients who have a rare and life-threatening disease mutation, developed by Astellas Pharma Inc.

The U.S. FDA approved Agios Pharmaceuticals’ oral leukemia treatment Tibsovo (ivosidenib).

  MaxiNovel Pharmaceuticals, Inc. Announces FDA Orphan Drug Designation for MAX-40279 for the Treatment of Acute Myeloid Leukemia (AML)   GUANGZHOU, China–(BUSINESS WIRE)–MaxiNovel Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (“FDA”) has granted MaxiNovel Orphan Drug Designation for MAX-40279 in the treatment of Acute Myeloid Leukemia (AML). AML is the most […]

Swiss drugmaker Novartis won European Union approval for Rydapt to be used against a mutated form of acute myeloid leukemia (AML) and other rare diseases.