AstraZeneca AZN and Ionis Pharmaceuticals IONS announced that the Committee for Medicinal Products for Human Use (CHMP) has ...

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

Four months after Europe's Committee for Medicinal Products for Human Use (CHMP) rejected Apellis’ GA application for Syfovre for a second time, Astellas has withdrawn its application for the approval ...

Astellas has announced the withdrawal of its MAA for ACP from the EMA to treat geographic atrophy (GA) secondary to AMD.

Europe's Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for two vaccines: Fluad (surface antigen, inactivated, adjuvanted) and Flucelvax ...

with first data readout expected in summer 2025 European Committee for Medicinal Products for Human Use (CHMP) review of vilobelimab continues, with discussions ongoing and a CHMP opinion anticipated ...

On October 17, the EMA's Committee for Medicinal Products for Human Use concluded that the Siiltibcy skin test showed favorable results compared with two other diagnostic products. Manufactured by ...

Madrigal Pharmaceuticals' Rezdiffra has favorable initial market adoption and FDA approval. Read why I maintain my buy rating ...

This decision follows the positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA). Authorization was based on non-clinical data that showed ...

EMA committee recommends approval of LINDIS Biotech’s Korjuny to treat malignant ascites MA in adults with EpCAM-positive carcinomas: Munich, Germany Wednesday, October 23, 2024 ...

NDA and MAA for govorestat for treatment of Classic Galactosemia under FDA Priority Review and EMA review; PDUFA target action date of November ...