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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…
Resverlogix Receives Approval Pathway from the FDA as to the Inclusion of USA Patients in the Phase en-cphi.cn
July 26, 2017
"BETonMACE Phase 3 Trial with apabetalone to expand to include the United States"
FDA Expands Approval of Yervoy (ipilimumab) to Include Pediatric Patients 12 Years and Older with Un drugs.com
July 26, 2017
Bristol-Myers Squibb Company (NYSE:BMY) announced that FDA has expanded the indication for Yervoy (ipilimumab) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and olde
FDA Chief plans regulatory overhaul to tackle US opioid crisis pharmafile
July 26, 2017
The US faces an ongoing crisis in opioid dependency, and FDA Commissioner Scott Gottlieb is prepared to employ unusual tactics to tackle the problem

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