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Sarepta Therapeutics Receives Complete Response Letter from the FDA for Golodirsen New Drug…

Aug 20, 2019
Sarepta Therapeutics announced it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) seeking…
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EAG Laboratories Launches New Laboratory in China

Aug 19, 2019
EAG Laboratories proudly announces the launch of a new laboratory in China dedicated to improving materials, products and electronics. Newly built in Shanghai, this facility brings the…
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EMA Validates Marketing Application for Filgotinib for the Treatment of Rheumatoid Arthritis

Aug 16, 2019
Gilead Sciences, Inc. and Galapagos NV announced that the Marketing Authorization Application (MAA) for filgotinib, an investigational, oral, selective JAK1 inhibitor, for the treatment…
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FDA Approves Genentech’s tumor-agnostic medicine Rozlytrek

Aug 16, 2019
Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) has approved Rozlytrek™ (entrectinib) for the treatment of adults with ROS1-positive,…
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Harmony Biosciences Announces FDA Approval Of WAKIX (Pitolisant)

Aug 16, 2019
Harmony Biosciences, LLC (Harmony) announced that the U.S. Food and Drug Administration (FDA) approved WAKIX (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in…
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Registration is now open for the Pre-filled Syringes and Injectable devices Conference 2020

Aug 16, 2019
SMi Reports: Registration is open for SMi Group’s 12th annual conference and exhibition taking place in January 2020 in London. As Europe’s leading Pre-Filled Syringes conference,…
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Discover the Next Big Thing in Neuromuscular Therapeutics

Aug 16, 2019
The Neuromuscular Drug Development Summit Returns to Boston in October The 2nd Neuromuscular Drug Development Summit, or NMD, will be held in Boston, MA, from October 23-25, 2019. This…
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GeneCentric Therapeutics Acquires Select ImmunoGenomics

Aug 15, 2019
GeneCentric Therapeutics, Inc. announced that it has acquired Select ImmunoGenomics, LLC, a Chapel Hill, NC-based provider of advanced immunogenomic, data analysis and biomarker…
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Phio Pharmaceuticals and Helmholtz Zentrum München to Collaborate on Novel Targets

Aug 15, 2019
Phio Pharmaceuticals Corp. announced that is has entered into a research collaboration with the Helmholtz Zentrum München. The agreement covers the design and development of new targets…
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Syapse Announces Research Collaboration with the FDA Focused on the Regulatory Use of Real-World…

Aug 15, 2019
Syapse and the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) have signed a multi-year Research Collaboration Agreement (RCA) focused on the use of…
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Press Releases

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