FDA to review isatuximab as a potential treatment for relapsed/refractory multiple myeloma

10 July 2019 - The U.S. FDA has accepted for review the biologics license application for isatuximab for the treatment ...

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Pacira BioSciences announces validation of Exparel marketing authorisation application from European Medicines Agency

25 June 2019 - Advances global expansion strategy to minimise post-surgical opioid use worldwide. ...

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Astellas announces acceptance of Xospata (gilteritinib) for regulatory review by the European Medicines Agency

28 February 2019 - Astellas Pharma announced today that the submission for a marketing authorisation application for the oral once-daily ...

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Bevespi Aerosphere approved in the EU for chronic obstructive pulmonary disease

20 December 2018 - AstraZeneca today announced that the European Commission has approved Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in a pressurised metered-dose ...

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Biosimilar pegfilgrastim co-developed by Biocon receives approval in EU

30 November 2018 - Fulphila, a biosimilar pegfilgrastim jointly developed by Biocon and Mylan, has been approved in EU.  ...

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Novartis announces FDA and EMA filing acceptance of siponimod, the first and only drug shown to meaningfully delay disability progression in typical SPMS patients

8 October 2018 - If approved, siponimod (BAF312) would be the first oral disease-modifying therapy with the potential to delay progression ...

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Novelion Therapeutics announces marketing authorisation for Myalepta (metreleptin) in the European Union to treat generalised and partial lipodystrophy

31 July 2018 - Myalepta is the first approved therapy in Europe indicated as an adjunct to diet as a replacement ...

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U.S. FDA and European Medicines Agency accept regulatory submissions for review of dacomitinib to treat metastatic non-small-cell lung cancer with EGFR-activating mutations

4 April 2018 - FDA priority review granted for U.S. new drug application. ...

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Ultragenyx announces recombinant human beta-glucuronidase biologics license application and marketing authorisation application filed and accepted for review; FDA grants priority review status

23 May 2017 - Ultragenyx today announced that a biologics license application submitted to the U.S. FDA and a marketing ...

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European Medicines Agency validates application for Bristol-Myers Squibb’s Sprycel (dasatinib) in children with chronic myelogenous leukaemia

19 May 2017 - Proposal extends application to the treatment of children and adolescents with chronic phase Philadelphia-chromosome positive chronic myelogenous ...

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