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FDA approves Celgene and Agios' acute myeloid leukaemia drug pharmafile
August 03, 2017
The FDA has given its approval for the commercialisation of Celgene and Agios Pharmaceutical’s Idhifa for the treatment of relapsed or refractory acute myeloid leukaemia (AML) in patients with an IDH2 mutation, it has emerged.
FDA approves new targeted treatment for acute myeloid leukemia europeanpharmaceuticalreview
August 03, 2017
The U.S. Food and Drug Administration has granted the approval of Idhifa to Celgene Corporation and RealTime IDH2 Assay to Abbott Laboratories…
New targeted treatment for relapsed or refractory acute myeloid leukemia approved by FDA biospectrumasia
August 03, 2017
Idhifa is an isocitrate dehydrogenase-2 inhibitor that works by blocking several enzymes that promote cell growth
FDA grants Breakthrough Therapy Designation status for acalabrutinib europeanpharmaceuticalreview
August 02, 2017
It has been announced that the FDA has awarded AstraZeneca’s acalabrutinib product for MCL treatment Breakthrough Therapy Designation.
FDA Approves KALYDECO (ivacaftor) for More Than 600 People Ages 2 and Older With Cystic Fibrosis Who firstwordpharma
August 02, 2017
Vertex Pharmaceuticals Incorporated announced that the U.S. FDA has approved KALYDECO® (ivacaftor) for use in more than 600 people with cystic fibrosis (CF) ages 2 and older who...
FDA Approves Idhifa drugs.com
August 02, 2017
FDA Approves Idhifa (enasidenib) for Relapsed or Refractory Acute Myeloid Leukemia with IDH2 Mutation
Dynavax Announces FDA Advisory Committee Vote in Favor of Heplisav-B drugs.com
August 01, 2017
Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 12 to 1 that the safety data for Heplisav-B...
FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death worldpharmanews
July 31, 2017
FDA announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death. The approach places nicotine,
FDA grants fast-track status for Ablynx’s caplacizumab to treat aTTP pharmaceutical-technology
July 31, 2017
Belgian biopharmaceutical company Ablynx has received fast-track designation from the US Food and Drug Administration (FDA) for its caplacizumab treatment for acquired thrombotic thrombocytopenic purpura (aTTP).
FDA launches Supply Chain Security Toolkit for Medical Products europeanpharmaceuticalreview
July 31, 2017
The U.S Food and Drugs Administration (FDA) has led a collaboration to create a Supply Chain Security Toolkit for Medical Products to maximise the available global resources and to deliver quality training and best practices for medical products…

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