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

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 ...
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 ...
FOX59 News

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. (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases ...
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 ...
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 ...
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 ...
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 ...
FOX40 News

Pfizer and BioNTech Receive Positive CHMP Opinion for Conversion of COMIRNATY® Conditional Marketing Authorization to Full Marketing Authorization in the European Union

Standard marketing authorization recommendation applies to all indications and formulations in the European Union, including COMIRNATY® Original/Omicron BA.4-5 and COMIRNATY® Original/Omicron BA.1 ...
Morningstar

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

ImmunityBio (NASDAQ: IBRX), a leading immunotherapy company, announced today that the European Medicines Agency has recommended granting a conditional marketing authorization in the EU for ANKTIVA® ...