Odessa American

Celltrion’s COVID-19 Treatment Candidate Receives Korean MFDS Conditional Marketing Authorisation

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 ...
Nasdaq

CHMP Issues Negative Opinion for Renewal of Conditional Marketing Authorization for Translarna™ (ataluren) Following Re-examination Procedure

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 ...
Seeking Alpha

ImmunityBio Receives Conditional Marketing Authorization Recommendation from the European Medicines Agency for ANKTIVA® with BCG for Non-Muscle Invasive Bladder Cancer ...

CULVER CITY, Calif.--(BUSINESS WIRE)-- ImmunityBio (IBRX) (NASDAQ: IBRX), a leading immunotherapy company, announced today that the European Medicines Agency has recommended granting a conditional ...
Seeking Alpha

Belite Bio Announces UK’s Medicines and Healthcare Products Regulatory Agency Agrees to Conditional Marketing Authorization Application Based on Interim Analysis Results for ...

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 ...
Business Wire

Gilead’s Seladelpar Granted Conditional European Marketing Authorization for the Treatment of Primary Biliary Cholangitis

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) has granted conditional marketing authorization for seladelpar for the ...
Healio

European Commission grants conditional marketing authorization to Filspari

Please provide your email address to receive an email when new articles are posted on . Filspari is intended for adults with primary IgA nephropathy who have a urine protein excretion of at least 1 ...
Reuters

MolMed receives positive CHMP opinion recommending conditional marketing authorisation for Zalmoxis

* The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), in conjunction with the Committee for Advanced Therapies (CAT), has issued a positive opinion ...