Tag: European Commission

European Commission Approved Roche Kadcyla®

Roche announced that the European Commission has approved Kadcyla® (trastuzumab emtansine) for the adjuvant (after surgery) treatment of adult patients with HER2-positive early breast cancer (eBC) who...

EC Granted Marketing Authorization for EVENITY®

UCB and Amgen announced that the European Commission (EC) has granted marketing authorization for EVENITY® (romosozumab) for the treatment of severe osteoporosis in postmenopausal women at high risk o...

European Regulators Approved Expanding Treatment Scope of Kalydeco

cystic-fibrosis
European regulators have approved expanding the treatment scope of Vertex’ cystic fibrosis (CF) therapy Kalydeco (ivacaftor). The decision allows for the drug’s use in infants with the condition ag...

Celltrion Remsima Approved by EU

celltrion
Celltrion has revealed data from its Remsima SC (infliximab) trials, evaluating a subcutaneous (SC) biosimilar version of the treatment in patients with Chron’s disease, ulcerative colitis and rheumat...

EC and UK OECD Stressed Importance of Generics and Biosimilars for Healthcare Systems

A joint report has been issued by the European Commission (EC) and the UK Organisation for Economic Co-operation and Development (OECD) on healthcare in the EU, highlighting the importance of generics...

Celltrion Healthcare Secured Approval from European Commission for Remsima

celltrion
Celltrion Healthcare has secured approval from the European Commission (EC) for its Remsima SC (CT-P13 SC), a biosimilar to Janssen Biotech’s infliximab, to treat patients with rheumatoid arthritis (R...

EC Approved KEYTRUDA as HNSCC Treatment

Merck, known as MSD outside the United States and Canada, announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy or in combination with platinum and 5-...

European Commission Approved AstraZeneca Qtrilmet

diabetes
AstraZeneca announced that the European Commission has approved Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets to improve glycaemic control in adults with t...

DARE!! Services B.V. Designated NB under Medical Devices Regulation

EU flag
The European Commission announced that Netherlands-based notified body (NB) DARE!! Services B.V. has been designated as the sixth NB under the incoming Medical Devices Regulation (MDR). DARE!! is d...

GSK Benlysta Approved in EU

gsk
GlaxoSmithKline plc announced that the European Commission has adopted a decision to extend to children five years and older, the existing adult indication for intravenous Benlysta (belimumab) as add-...

European Commission Approved New Indication for Dupixent®

The European Commission (EC) approved a new indication for Dupixent® (dupilumab) in chronic rhinosinusitis with nasal polyposis (CRSwNP). Dupixent is indicated as an add-on therapy with intranasal c...

EC Approved BAVENCIO® for Advanced Renal Cell Carcinoma Treatment

merck kgaa
Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the US and Canada, and Pfizer Inc. announced that the European Commission (EC) has approved BAVENCIO® (av...

European Commission Approved Astellas Therapy XOSPATA™

drug-development
Astellas Pharma Inc. announced that the European Commission (EC) has approved the oral once-daily therapy XOSPATA™ (gilteritinib) as a monotherapy for the treatment of adult patients with relapsed or ...

BMS Gets EC Approval for Opdivo

bms
Bristol-Myers Squibb Company announced that the European Commission (EC) has approved Opdivo (nivolumab) flat dosing schedule of 240 mg infused over 30 minutes every two weeks (Q2W) or 480 mg infused ...

European Commission Approved Label Update for Up-Titration of Cosentyx

European-Commission
Novartis, a leader in rheumatology and immuno-dermatology, announced today that the European Commission (EC) has approved a label update for the up-titration of Cosentyx (secukinumab) to 300 mg for pa...

EMA Released MDR Guidance which Addresses Transitional Provisions

European-Commission
The European Commission’s Medical Device Coordination Group (MDCG) released guidance to further explain Article 120(2) of the EU Medical Devices Regulation (MDR), which says that certificates issued i...