Nasdaq

Autolus Therapeutics Receives Conditional Marketing Authorisation from MHRA for AUCATZYL® to Treat Adult Patients with Relapsed or Refractory B-ALL

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

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 ...