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RSS FeedPosted by Michael Wonder on 20 Nov 2019
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 ...
Posted by Michael Wonder on 20 Nov 2019
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 ...
Posted by Michael Wonder on 19 Nov 2019
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 ...
Posted by Michael Wonder on 17 Nov 2019
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 ...
Posted by Michael Wonder on 15 Nov 2019
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 ...
Posted by Michael Wonder on 14 Nov 2019
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 ...
Posted by Michael Wonder on 13 Nov 2019
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 ...
Posted by Michael Wonder on 09 Nov 2019
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 ...
Posted by Michael Wonder on 09 Nov 2019
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 ...
Posted by Michael Wonder on 09 Nov 2019
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 ...
Posted by Michael Wonder on 07 Nov 2019
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 ...
Posted by Michael Wonder on 01 Nov 2019
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 ...
Posted by Michael Wonder on 31 Oct 2019
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. ...
Posted by Michael Wonder on 30 Oct 2019
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. ...
Posted by Michael Wonder on 29 Oct 2019
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. ...