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

ImmunityBio Receives Authorization from the European Commission for ANKTIVA® with BCG for Non-Muscle Invasive Bladder Cancer Carcinoma in Situ, Expanding Global Access to 33 ...

CULVER CITY, Calif.--(BUSINESS WIRE)-- ImmunityBio (IBRX) (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that the European Commission has granted conditional marketing ...
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 ...
News Medical

MHRA grants conditional marketing authorization for AbbVie's Tepkinly to treat aggressive blood cancer

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 ...
RAPS

EU official: Regulatory requirements for conditional marketing authorization ‘evolving’

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 ...
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 ...