The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the application for conditional marketing authorisation of AMX0035, ...

Autolus Therapeutics plc announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation for AUCATZYL (obecabtagene autoleucel) to ...

SOUTH PLAINFIELD, N.J., Jan. 25, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines ...

Ten years after the development of the conditional marketing authorization (CMA) pathway, European Medicines Agency (EMA) on Monday said the program is working as intended, and has led to earlier ...

BRUSSELS – Regulatory requirements for conditional marketing authorizations (CMAs) are “evolving” and more complicated than in the past in terms of demonstrating a product’s major therapeutic ...

Celltrion Group today announced that the Korean Ministry of Food and Drug Safety (MFDS) granted a Conditional Marketing Authorisation (CMA) for the emergency use of Regdanvimab (CT-P59), an anti-COVID ...

AB Science SA (Euronext - FR0010557264 - AB) today announced that it has filed an application for conditional Marketing Authorization to the European Medicines Agency (EMA) for Alsitek (masitinib) in ...

SAN DIEGO, Nov. 02, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (BLTE) (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal ...

Sinovac Biotech Ltd. (NASDAQ:SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, today announced that the China National Medical Products Administration (NMPA ...

Amylyx Pharmaceuticals, Inc. AMLX ("Amylyx" or the "Company") today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a ...