Feb 19, 2021
Dynavax Announces European Commission Marketing Authorization for HEPLISAV B®, a 2 Dose Adult Hepatitis B Adjuvanted Vaccine
Jan 06, 2021
Panalgo's IHD Platform to Be Used by the European Medicines Agency for Real-World Data Analytics
Dec 28, 2020
Introducing COMIRNATY®, the EU Brand Name for Pfizer & BioNTech's COVID-19 Vaccine, Developed by Brand Institute
Aug 13, 2020
European Medicines Agency Validates BioMarin's Marketing Authorization Application for Vosoritide to Treat Children with Achondroplasia
Jun 29, 2020
PTC Therapeutics Announces CHMP Recommendation of Translarna(TM) (ataluren) Label Update for Non-Ambulatory Patients with Duchenne Muscular Dystrophy
Jun 15, 2020
WuXi Biologics (Suzhou) Received EMA GMP Certificate for Biosafety Testing
Jun 01, 2020
Henlius and Accord Receive Positive CHMP Opinion for Oncology Biosimilar, HLX02 (Trastuzumab)
May 25, 2020
Hansa Biopharma Submits Responses to Outstanding Questions From EMA on May 26
May 14, 2020
Nordic Nanovector's Betalutin® Receives Positive Opinion for Orphan Drug Designation from EMA for Marginal Zone Lymphoma (MZL)
May 13, 2020
OncoSec's TAVO(TM) Receives ATMP Certification from European Medicines Agency to Support Marketing Authorization Application in Metastatic Melanoma
Apr 30, 2020
Medivir Receives Positive Opinion on Orphan Medicinal Drug Designation by the European Medicines Agency for MIV-818
Apr 27, 2020
CARsgen Therapeutics Receives Positive EMA Opinion on Orphan Drug Designation for Fully Human Anti-BCMA CAR-T Cells (CT053) for the Treatment of Multiple Myeloma
Jan 06, 2020
Kyowa Kirin Announces Marketing Authorisation Application for Istradefylline Validated by European Medicines Agency
Dec 23, 2019
European Medicines Agency Validates BioMarin's Marketing Authorization Application for Valoctocogene Roxaparvovec to Treat Severe Hemophilia A
Nov 21, 2019
BioMarin Submits Marketing Authorization Application to European Medicines Agency for Valoctocogene Roxaparvovec to Treat Severe Hemophilia A
Nov 19, 2019
Tarsius Pharma Announces Granting of Orphan Drug Designation for TRS by the European Medicines Agency
Oct 18, 2019
Rigel Receives Positive Trend Vote from CHMP for Fostamatinib Disodium Hexahydrate for Adult Patients with Chronic Immune Thrombocytopenia (ITP) in Europe
Oct 10, 2019
Kindred Biosciences Announces Positive Opinion from CVMP in the European Union for Mirataz® (mirtazapine transdermal ointment) for Cats Experiencing Poor Appetite and Weight Loss
Sep 23, 2019
CARsgen Announces Investigational CAR-T Therapy CT053 Granted PRIME Eligibility by the European Medicines Agency
Jul 19, 2019
Halozyme Announces Janssen Submits Extension Application To European Medicines Agency For Subcutaneous Formulation Of DARZALEX® Utilizing ENHANZE® Technology