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.
The U.S. Food and Drug Administration approved Pfizer Inc.’s drug Mylotarg for certain patients with acute myeloid leukemia (AML), re-clearing a drug that had been pulled off the market in 2010.
The U.S. FDA approved Celgene Corp. and Agios Pharmaceuticals Inc.’s oral treatment for acute myeloid leukemia patients with a specific genetic mutation.
The biotech industry did OK in July 2017. The NYSE ARCA Biotech Index and the iShares NASDAQ Biotechnology Index (ETF) grew about 1.9 percent and 2.9 percent, respectively last month. There have been 26 new molecular entity approvals so far this year. With that figure in mind, here are eight companies looking at PDUFA dates in August 2017.
ZURICH (Reuters) – A European Medicines Agency (EMA) panel recommended on Friday approval of a new Novartis drug to be used against a tough-to-cure form of blood cancer as the Swiss drugmaker makes headway on refreshing its oncology portfolio. The EMA’s Committee for Medicinal Products for Human Use (CHMP) backed Rydapt against acute myeloid leukemia […]
The U.S. FDA placed a hold on Seattle Genetics’ Investigational New Drug Application for vadastuximab talirine.