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

On Friday, Novartis AG (NYSE:NVS) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for ...

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

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

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

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 ...

The European Commission (EC) will decide in approximately two months. Last month, Novartis released new data from the ALITHIOS open-label extension study. Data show first-line Kesimpta (ofatumumab ...

Vutrisiran treatment leads to a decrease in serum vitamin A levels. Supplementation of approximately, but not exceeding, 2500 IU to 3000 IU vitamin A per day is advised for patients taking vutrisiran.

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 ...