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RSS FeedPosted by Michael Wonder on 02 Aug 2017
FDA approves Kalydeco (ivacaftor) for more than 600 people ages 2 and older with cystic fibrosis who have certain residual function mutations
1 August 2017 - Vertex Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Kalydeco (ivacaftor) ...
Posted by Michael Wonder on 02 Aug 2017
AiCuris granted fast track designation by U.S. FDA for oral pritelivir for treatment of HSV infections in immunocompromised adults
1 August 2017 - AiCuris today announced that the Company has been granted fast track designation by the U.S. FDA ...
Posted by Michael Wonder on 01 Aug 2017
FDA approves new targeted treatment for relapsed or refractory acute myeloid leukaemia
1 August 2017 - The U.S. FDA today approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory ...
Posted by Michael Wonder on 01 Aug 2017
Bristol-Myers Squibb receives FDA approval for Opdivo (nivolumab) in MSI-H or dMMR metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
1 August 2017 - Approval based on CheckMate -142, in which Opdivo demonstrated an objective response rate of 28% (95% CI: ...
Posted by Michael Wonder on 01 Aug 2017
Indivior RBP-6000 NDA acceptance with priority review designation
31 July 2017 - FDA sets a PDUFA target action date of 30 November 2017. ...
Posted by Michael Wonder on 31 Jul 2017
New system speeds FDA import decisions
31 July 2017 - The data is in. A new automated system for determining whether FDA regulated products can enter the ...
Posted by Michael Wonder on 31 Jul 2017
Imfinzi granted breakthrough therapy designation by US FDA for patients with locally-advanced unresectable non-small-cell lung cancer
31 July 2017 - Fourth breakthrough therapy designation for an AstraZeneca new oncology medicine in three years. ...
Posted by Michael Wonder on 31 Jul 2017
Celltrion and Teva announce U.S. FDA acceptance of biologics license application for proposed biosimilar to Herceptin (trastuzumab)
31 July 2017 - Celltrion and Teva Pharmaceuticals today announced that the U.S. FDA has accepted for review the biologics license ...
Posted by Michael Wonder on 31 Jul 2017
Amgen submits supplemental biologics license application for Prolia (denosumab) in glucocorticoid-induced osteoporosis
31 July 2017 - Amgen today announced the submission of a supplemental biologics license application to the U.S. FDA for Prolia ...
Posted by Michael Wonder on 31 Jul 2017
Amgen and Allergan submit biosimilar biologics license application for ABP 980 to US Food And Drug Administration
31 July 2017 - Filing for ABP 980, a biosimilar candidate to Herceptin (trastuzumab), supported by phase 3 data in ...
Posted by Michael Wonder on 30 Jul 2017
FDA accepts biologics license application for Aimovig (erenumab)
20 July 2017 - Aimovig is an Investigative migraine-specific preventive therapy designed for patients with high unmet need. ...
Posted by Michael Wonder on 30 Jul 2017
Roche leukaemia drug gets FDA breakthrough therapy designation
28 July 2017 - Roche Holding AG's Venclexta has won breakthrough therapy designation in acute myeloid leukaemia from the U.S. ...
Posted by Michael Wonder on 29 Jul 2017
FDA grants priority review for Amgen's supplemental biologics license application for Repatha (evolocumab) to include data on reducing risk of cardiovascular events
28 July 2017 - FDA priority review status underscores need to reduce heart attacks and strokes. ...
Posted by Michael Wonder on 29 Jul 2017
Abilify Maintena® (aripiprazole) for extended-release injectable suspension approved by the U.S. FDA for maintenance monotherapy treatment of bipolar I disorder
28 July 2017 - New indication for Abilify Maintena is based on studies evaluating efficacy and safety in adult patients with ...
Posted by Michael Wonder on 28 Jul 2017
Aradigm submits new drug application to FDA for U.S. marketing approval of Linhaliq in non-cystic fibrosis bronchiectasis
27 July 2017 - Aradigm Corporation today announced it has submitted its new drug application to the U.S. FDA for ...