Business Wire

Amylyx Pharmaceuticals Receives CHMP Negative Opinion on its Conditional Marketing Authorisation Application for AMX0035 for the Treatment of ALS in the European Union

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the ...
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

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 ...
MarketWatch

Wegovy(R) (semaglutide injection) Receives Conditional Marketing Authorization from Health Canada as the First and Only Treatment for Adults with Non-Cirrhotic MASH, a Serious ...

The MarketWatch News Department was not involved in the creation of this content. -- Wegovy(R) (semaglutide injection) granted conditional marketing authorization for the treatment of non-cirrhotic ...
WRBL

Calliditas Receives Conditional Marketing Authorization from UK MHRA for Kinpeygo in IgA nephropathy

STOCKHOLM, Feb. 2, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the Medicines and Healthcare products Regulatory Agency ...
Seeking Alpha

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

– Now Approved, Seladelpar Can Provide an Important Treatment Option for People Living With the Rare Liver Disease in the European Economic Area – – First and Only Treatment That Achieved ...