Tag: EC

Two More Countries Entered EU-FDA Mutual Recognition Agreement

On 10 June 2019, Luxembourg and the Netherlands were included into the mutual recognition agreement between the European Union (EU) and the United States Food and Drug Administration (FDA). The FDA th...

bluebird bio Drug for Severe Genetic Disease Approved by EC

bluebird bio, Inc. announced that the European Commission (EC) has granted conditional marketing authorization for ZYNTEGLO™ (autologous CD34+ cells encoding βA-T87Q-globin gene), a gene therapy for p...

EC Granted BioMarin with Marketing Authorization for Palynziq

biomarin
BioMarin Pharmaceutical Inc. announced that the European Commission (EC) has granted marketing authorization for Palynziq® (pegvaliase injection) at doses of up to 60 mg once daily, to reduce blood ph...

EC Approved Dupixent for Severe Asthma

The European Commission has approved Dupixent® (dupilumab) for use in adults and adolescents 12 years and older as an addon maintenance treatment for severe asthma with type 2 inflammation characteriz...

EС Approved Pfizer’s LORVIQUA®

Pfizer Inc. announced today that the European Commission (EC) granted conditional marketing authorization for LORVIQUA® (lorlatinib, available in the U.S., Canada and Japan under the brand name LORBRE...

ThiIrd Lynparza Indication in EU

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced the European Commission has approved Lynparza (olaparib) as a monotherapy ...

EC Granted Marketing Authorization Teva’s Migraine Med

Teva Pharmaceutical Industries Ltd. announced that the European Commission (EC) has granted the Marketing Authorization for AJOVY (fremanezumab) 225 mg solution for injection in pre-filled syringe for...

First Approved AZ’s Med for Type-1 Diabetes

Forxiga is the first oral medicine approved in Europe as an adjunct to insulin for adults with type-1 diabetes and the first AstraZeneca medicine ever approved for type-1 diabetes. The European Com...

EC Approved New Indication for Sanofi’s Praluent

Praluent is the only EU-approved PCSK9 inhibitor with cardiovascular outcomes data that showed an association with reduced death from any cause. The European Commission (EC) has approved a new indi...

EC Approved Keytruda in Combination with Chemotherapy

KEYTRUDA is First Anti-PD-1 Therapy Approved in Combination with Chemotherapy in Europe for Adults with Metastatic Squamous NSCLC Regardless of PD-L1 Expression. Merck, known as MSD outside the Uni...

EC Approved Roche’s Hemlibra

First medicine to significantly reduce treated bleeds compared to prior factor VIII prophylaxis, in a prospective intra-patient comparison. Roche today announced that the European Commission has ap...

EC Approval for Roche’s Treatment of NSCLC

roche
Roche today announced that the European Commission has approved and granted marketing authorisation for Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab), paclitaxel and carboplatin...

EC Approved Takeda’s ADCETRIS 

ADCETRIS in Combination with AVD (Adriamycin, Vinblastine and Dacarbazine) Demonstrated 29-Percent Reduction in the Risk of Progression, Death or Need for Additional Anticancer Therapy for CD30+ Stage...

EC Approved Clovis Drug for Relapsed Ovarian Cancer

Clovis Oncology has secured approval from the European Commission (EC) for its Rubraca (rucaparib) as maintenance treatment for women with relapsed ovarian cancer. The second indication of Rubraca ...

Expanded Indication from EC for Amgen’s Drug

Amgen announced that the European Commission (EC) has approved an expanded indication for BLINCYTO (blinatumomab) monotherapy to include adult patients with Philadelphia chromosome negative (Ph-) CD19...