The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has once again snubbed Translarna ...

The opinion rejects granting conditional marketing authorization to AB Science’s masitinib as an oral add-on treatment for ALS in the EU.

Novartis' Kisqali receives a positive recommendation from EMA's CHMP for adjuvant treatment of early breast cancer, showing a ...

Christian Meyer and Gisela Grabow of Maiwald discuss potential changes to the EU pharmaceutical regulation and their ...

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for ...

Novartis NVS announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (EMA ...

Post-Marketing Confirmatory Study DBV and FDA are in general agreement that the confirmatory study will need to demonstrate the effectiveness of the Viaskin Peanut patch and will need to be initiated ...

Alnylam Pharmaceuticals (ALNY) announced the submission of a Type II Variation to the European Medicines Agency for vutrisiran, an ...

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the European Medicines Agency (EM ...

Evergreen Theragnostics opens trial of 68Ga-EVG321 for patients with small cell lung cancer in European Union: Springfield, New Jersey Monday, October 21, 2024, 18:00 Hrs [IST] Ev ...