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26.11.2020 – 17:37

Merck KGaA
European Medicines Agency Validates Application for Tepotinib for the Treatment of Advanced NSCLC with METex14 Skipping Alterations

Darmstadt, Germany (ots/PRNewswire) - Merck, a leading science and technology company, today announced that the European Medicines Agency (EMA) has validated for review, the application for tepotinib for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial ...

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30.09.2020 – 13:00

BrainRepair UG

Regulatory breakthrough for BrainRepair UG start-up - Stem cell treatment for newborns /EMA Orphan Drug Designation is followed by agreement on Paediatric Investigation Plan

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06.01.2020 – 10:00

Kyowa Kirin International PLC
Kyowa Kirin Announces Marketing Authorisation Application for Istradefylline Validated by European Medicines Agency

Tokyo (ots/PRNewswire) - Kyowa Kirin Co., Ltd. (TSE: 4151) President and CEO: Masashi Miyamoto, "Kyowa Kirin") today announces that its marketing authorisation application (MAA) for istradefylline (KW-6002) as an adjunctive treatment to levodopa-based regimens in adult patients with Parkinson's disease (PD) ...

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20.12.2018 – 16:01

Merck KGaA
Merck Announces EMA Orphan Drug Designation for Bifunctional Immunotherapy M7824 in Biliary Tract Cancer

Darmstadt, Germany (ots/PRNewswire) - The information contained is not intended for distribution in the USA, Canada or the UK - European Medicine Agency (EMA) grants M7824, an investigational bifunctional immunotherapy, orphan drug designation in biliary tract cancer (BTC) - EMA orphan drug designation for M7824 in ...

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20.05.2011 – 16:37

Astellas Pharma Europe Limited
Astellas Receives Positive Opinion From CHMP for European Approval of VIBATIV(TM) for Nosocomial Pneumonia Caused by MRSA

Staines, England (ots/PRNewswire) - Astellas Pharma Europe Ltd., announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of marketing authorisation for VIBATIV (telavancin hydrochloride) for the ...

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