Alkermes submits new drug application to U.S. FDA for ALKS 3831 for treatment of schizophrenia and bipolar I disorder

19 November 2019 - Alkermes today announced that it has submitted a new drug application to the U.S. FDA seeking ...

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Medexus granted priority review status for Gliolan by Health Canada

19 November 2019 - Medexus Pharmaceuticals today announced that Health Canada has granted priority review status for the new drug ...

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FDA accepts Samsung Bioepis’ BLA for SB8 bevacizumab biosimilar candidate

19 November 2019 - Samsung Bioepis today announced that the U.S. FDA has accepted for review the company’s biologics license ...

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Tricida announces FDA acceptance of new drug application for veverimer

14 November 2019 - Tricida announced today that the U.S. FDA has accepted for review its new drug application for ...

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Valeo Pharma announces filing of a new drug submission for low molecular weight heparin in Canada

14 November 2019 - Valeo Pharma announced today that the new drug submission filed for a low molecular weight heparin ...

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US FDA accepts regulatory submission for selumetinib in neurofibromatosis type 1 and grants priority review

14 November 2019 - AstraZeneca and MSD’s selumetinib would become the first medicine indicated for the treatment of paediatric patients with ...

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Actelion withdraws regulatory filings to extend the indication of Opsumit (macitentan 10mg) in CTEPH

12 November 2019 - Actelion Pharmaceuticals has announced its decision to voluntarily withdraw the European and other health authority filings ...

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Cassiopea announces FDA acceptance of its new drug application for clascoterone 1% cream, the first new mechanism of action for acne in nearly 40 years

8 November 2019 - Cassiopea announced today the U.S. FDA has accepted for review the new drug application for clascoterone cream ...

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Johnson & Johnson announces submission of European marketing authorisation applications for Janssen’s investigational Ebola vaccine regimen

7 November 2019 - Data from multiple preclinical, Phase 1, 2 and 3 studies support applications, which have been granted Accelerated ...

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Janssen announces submission of supplemental new drug application to U.S. FDA seeking approval of Imbruvica (ibrutinib) in combination with rituximab for previously untreated patients with chronic lymphocytic leukaemia

8 November 2019 - Supplemental new drug application -- submitted through FDA real-time oncology review program -- is based on positive ...

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EMA validates Bratovi, Mektovi application for some mCRC

7 November 2019 - The EMA has validated Pierre Fabre’s application for a Braftovi (encorafenib) and Mektovi (binimetinib) combination for ...

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Vertex announces EMA marketing authorisation application validation for VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination treatment in cystic fibrosis

31 October 2019 - Application supported by positive results from two global Phase 3 studies in people with cystic fibrosis ages ...

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FDA grants appeal to Recro Pharma for IV meloxicam new drug application

31 October 2019 - Received positive response from FDA regarding IV meloxicam formal dispute resolution request. ...

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EMA and FDA accept marketing applications for Chugai's satralizumab in neuromyelitis optica spectrum disorder

30 October 2019 - The applications will be reviewed under accelerated assessment by EMA. ...

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Omeros Corporation initiates BLA submission for narsoplimab for the treatment of HSCT-TMA

28 October 2019 - Rolling submission of the remaining BLA sections continues on track for scheduled completion 1H 2020. ...

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