Autolus Therapeutics plc announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation for AUCATZYL (obecabtagene autoleucel) to ...
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, ...
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 ...
AbbVie today announced that the UK Medicines and Healthcare products Regulatory Agency has granted conditional Marketing Authorisation for Tepkinly ® (epcoritamab) as a monotherapy for the treatment ...
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 ...
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 ...
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