European Commission (EC)
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259 articles with European Commission (EC)
GW Pharmaceuticals receives European Commission approval for EPIDYOLEX® (cannabidiol) for the treatment of seizures associated with tuberous sclerosis complex
TSC causes epilepsy in up to 85% of patients, and up to 60% of those patients do not respond to standard anti-epileptic medicines
Amarin Commences Commercial Initiatives for VAZKEPA in European Union Following Recent Regulatory Approval for Cardiovascular Risk Reduction Indication
Amarin Corporation plc provided updates regarding its plans for the commercial launch of VAZKEPA in Europe following the March 30, 2021 announcement of receipt of market authorization from the European Commission.
Passage Bio Receives European Commission Orphan Designation for PBKR03 for Treatment of Krabbe Disease
Passage Bio, Inc., a clinical-stage genetic medicines company focused on developing transformative therapies for rare monogenic central nervous system disorders, announced that the European Commission has granted Orphan designation for PBKR03, an adeno-associated virus -delivery gene therapy for the treatment of Krabbe disease.
Exelixis’ Partner Ipsen Receives European Commission Approval for CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma
Approval based on CheckMate -9ER trial, in which CABOMETYX in combination with OPDIVO doubled progression-free survival and objective response rate while significantly improving overall survival versus sunitinib
European Commission Approves Cabometyx® in Combination With Opdivo® as a First-Line Treatment for Patients Living With Advanced Renal Cell Carcinoma
Ipsen announced that the European Commission has approved Cabometyx® in combination with Bristol Myers Squibb’s Opdivo® for the first-line treatment of advanced renal cell carcinoma.
PTC Therapeutics Announces the European Approval of Evrysdi™ for the Treatment of Spinal Muscular Atrophy
PTC Therapeutics, Inc. announced that the European Commission has granted marketing authorization to Evrysdi™ for the treatment of spinal muscular atrophy in patients 2 months and older.
Marks first and only EC-approved treatment to reduce cardiovascular risk in high-risk, statin-treated adult patients who have elevated triglycerides (≥150 mg/dL) and other risk characteristics as studied in REDUCE-IT®
CARsgen Therapeutics Receives Orphan Medicinal Product Designation from the European Medicines Agency for CT041 CLDN18.2 CAR T Cells for the Treatment of Gastric Cancers
CARsgen Therapeutics Holdings Limited, a clinical-stage biopharmaceutical company, announced that the European Commission has granted orphan designation for CT041, CARsgen's first-in-class Claudin 18.2 targeted CAR-T product candidate for the treatment of gastric cancer.
Zoetis Receives European Commission Marketing Authorization for Solensia® (frunevetmab), a New Therapy for Feline Osteoarthritis Pain
Solensia is the first injectable monoclonal antibody (mAb) licensed for alleviation of pain associated with osteoarthritis (OA) in cats
Pfizer Inc. and BioNTech SE announced an agreement with the European Commission to supply an additional 200 million doses of COMIRNATY®, the companies’ COVID-19 Vaccine, to the 27 European Union member states.
European Commission Approves BAVENCIO® (avelumab) for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma
BAVENCIO maintenance treatment significantly extended median overall survival versus standard of care in the Phase III JAVELIN Bladder 100 study
Swedish Orphan Biovitrum AB announces that the European Commission has approved an extension of the indication for Doptelet to include the treatment of primary chronic immune thrombocytopenia in adult patients who are refractory to other treatments in all European Union member states.
Moderna, Inc., a biotechnology company pioneering messenger RNA therapeutics and vaccines, announced that the European Commission has granted a conditional marketing authorization for COVID-19 Vaccine Moderna, allowing vaccination programs using the Moderna vaccine to be rolled out across the European Union.
Halozyme Announces Roche Receives EC Approval For Phesgo® (Fixed-Dose Combination Of Perjeta® And Herceptin® For Subcutaneous Injection) Utilizing Halozyme's ENHANZE® Technology For The Treatment Of Patients With HER2-Positive Breast Cancer
Phesgo® Can be Administered in 5 to 8 Minutes Compared with Hours for the Standard Sequential IV Administration of Perjeta® and Herceptin®
Kite’s Tecartus™ (KTE-X19) Granted Conditional Marketing Authorization for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma in Europe
Tecartus is First CAR T Therapy in Relapsed or Refractory MCL and Kite Becomes the First Company with Multiple Approved Cell Therapies in Europe
DGAP-News: MorphoSys' Licensee Announces Approval by the European Commission for Tremfya(R) (guselkumab) for Treatment of Adults with Active Psoriatic Arthritis (PsA)
MorphoSys AG announced that its licensee Janssen Research & Development, LLC. reported the European Commission's approval for the use of Tremfya in the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy.
Obiltoxaximab Receives Marketing Authorization From European Commission For The Treatment Of Inhalation Anthrax
Elusys Therapeutics, Inc. announced that the European Commission has approved obiltoxaximab, the company's monoclonal antibody anthrax antitoxin for the treatment of inhalation anthrax.
Dupixent® (dupilumab) Approved by European Commission as First and Only Biologic Medicine for Children Aged 6 to 11 Years with Severe Atopic Dermatitis
Pivotal trial showed more than four times as many children achieved itch reduction and more than three times as many children achieved clear or almost clear skin with Dupixent plus topical corticosteroids (TCS) compared to TCS alone
Vertex Announces European Commission Approval for SYMKEVI® (tezacaftor/ivacaftor) With KALYDECO® (ivacaftor) for Eligible Children With Cystic Fibrosis Ages 6-11 Years
The only medicine to treat the underlying cause of CF in this age group with one F508del mutation and one of 14 residual function mutations
Imara Receives Orphan Drug Designation from the European Commission for IMR-687 for the Treatment of Sickle Cell Disease
Imara Inc., a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin, announced that the European Commission granted Orphan Drug designation to IMR-687 for the treatment of patients with sickle cell disease.