European Medicines Agency (EMA)

798 articles with European Medicines Agency (EMA)

• Biogen Receives Favorable Decision from Court of Justice of the European Union Relating to TECFIDERA® (dimethyl fumarate) Regulatory Data and Marketing Protection

  3/16/2023

  Biogen Inc. announced that the Court of Justice of the European Union decided in favor of Biogen, the European Medicines Agency, and the European Commission in their appeal of a General Court decision annulling the EMA’s refusal to evaluate a generic version of TECFIDERA® because of TECFIDERA’s regulatory data and marketing protection.

• Genethon Given PRIME Status by EMA for Gene Therapy To Treat Crigler-Najjar Syndrome, a Rare Liver Disease

  3/7/2023

  Genethon, a unique non-profit gene therapy R&D organization founded by the French Muscular Dystrophy Association, announced that the European Medicines Agency has granted PRIME status to the gene therapy, GNT-0003, currently in clinical trials for Crigler-Najjar syndrome, a rare liver disease.

• AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults with Moderate to Severe Crohn's Disease

  2/27/2023

  AbbVie announced the European Medicines Agency's Committee for Medicinal Products for Human Use recommended the approval of upadacitinib for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.1-4

• Libtayo® (cemiplimab) in Combination with Chemotherapy Receives Positive CHMP Opinion for the Treatment of Advanced PD-L1 Positive Non-small Cell Lung Cancer (NSCLC)

  2/24/2023

  Regeneron Pharmaceuticals, Inc. announced the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for Libtayo® in combination with platinum-based chemotherapy.

• Pharming provides update on EMA regulatory review of leniolisib for APDS in Europe

  2/16/2023

  Pharming Group N.V. announces that the European Medicines Agency's Committee for Human Medicinal Products has decided to shift its assessment of the Marketing Authorisation Application for leniolisib to a standard review timetable.

• EMA Confirms Acceptance of Application for AVT04, a Proposed Biosimilar to Stelara® (ustekinumab)

  2/9/2023

  Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and global pharmaceutical company STADA Arzneimittel announced that the European Medicines Agency has accepted a Marketing Authorization Application for AVT04, Alvotech’s proposed biosimilar to Stelara®.

• Everest Medicines' Licensing Partner Pfizer Announces FDA and EMA Acceptance of Etrasimod Regulatory Submissions for Ulcerative Colitis

  12/22/2022

  Everest Medicines announced that its licensing partner, Pfizer Inc. has received acceptance from the U.S. Food and Drug Administration for review a New Drug Application for etrasimod for individuals living with moderately-to-severely active ulcerative colitis.

• Hansa Biopharma announces positive reimbursement decision in Italy for Idefirix® (imlifidase) as desensitization treatment for highly sensitized patients in kidney transplantation

  12/8/2022

  Hansa Biopharma announces that the Italian Medicine Agency has granted full access and reimbursement for the use of Idefirix®, the company's first-in-class treatment, for the desensitization of highly sensitized adult patients prior to kidney transplant from a deceased donor.

• Ascendis Pharma Submits Marketing Authorisation Application to the European Medicines Agency for TransCon™ PTH in Adult Patients with Hypoparathyroidism

  11/14/2022

  Ascendis Pharma A/S announced it has submitted a Marketing Authorisation Application to the European Medicines Agency for TransCon PTH in adult patients with hypoparathyroidism.

• Press Release: Dupixent® (dupilumab) recommended for EU approval by the CHMP for the treatment of prurigo nodularis

  11/11/2022

  The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending the approval of Dupixent® in the European Union to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.

• ProKidney Receives Allowance from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for proact 1 (REGEN-006) and EMA Scientific Advice on Phase 3 Protocols of REACT for Diabetic Chronic Kidney Disease

  11/3/2022

  ProKidney Corp., a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease, announced the allowance of the proact 1 Phase 3 study protocol for its investigational candidate REACT® by the United Kingdom’s MHRA.

• Pharming Announces European Medicines Agency (EMA) Validates its Marketing Authorisation Application under Accelerated Assessment for leniolisib

  10/28/2022

  Pharming Group N.V. announces that its Marketing Authorisation Application for leniolisib has been validated for scientific evaluation under an accelerated assessment by the European Medicines Agency's Committee for Medicinal Products for Human Use.

• EMA Committee for Medicinal Products for Human Use Issues Positive Opinion Recommending Authorization for the Use of Spikevax (mRNA-1273) in Children 6 Months - 5 Years in the European Union

  10/19/2022

  Moderna, Inc. announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion recommending a variation to the conditional marketing authorization to include a 25 µg two-dose series of Spikevax for active immunization to prevent coronavirus disease 2019 caused by SARS-CoV-2 in children 6 months to 5 years.

• EMA Committee For Medicinal Products For Human Use Adopts Positive Opinion Recommending Authorization Of Moderna's Omicron BA.4-BA.5 Targeting Bivalent Covid-19 Vaccine In The European Union

  10/19/2022

  Moderna, Inc. announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending conditional marketing authorization for mRNA-1273.222 as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older, who have previously received at least a primary vaccination course against COVID-19.

• BeiGene Receives Positive CHMP Opinion for BRUKINSA® (zanubrutinib) for the Treatment of Adults With CLL

  10/14/2022

  BeiGene announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending approval of BRUKINSA® for the treatment of adult patients with chronic lymphocytic leukemia.

• Pharming submits a Marketing Authorisation Application to the European Medicines Agency for Leniolisib

  10/11/2022

  Pharming Group N.V. announces that it has submitted a Marketing Authorisation Application to the European Medicines Agency for leniolisib, an oral, selective phosphoinositide 3-kinase delta inhibitor, as a treatment for activated phosphoinositide 3-kinase delta syndrome, a rare primary immunodeficiency, in adults and adolescents 12 years or older.

• Galapagos receives positive CHMP opinion for Jyseleca® European label update based on testicular function safety data from MANTA/RAy studies

  10/3/2022

  Galapagos NV announced that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company’s Type II variation application for Jyseleca®, a once-daily, oral, JAK1 preferential inhibitor, to amend the European label regarding testicular function after treatment of patients with inflammatory bowel disease and rheumatic conditions.

• European Medicines Agency Accepts Astellas' Marketing Authorization Application for Fezolinetant

  9/30/2022

  Astellas Pharma Inc. announced the European Medicines Agency has accepted for regulatory review the company's marketing authorization application for fezolinetant, an investigational oral, nonhormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms associated with menopause.

• European Medicines Agency Accepts Moderna's Conditional Marketing Authorization Filing for its Omicron BA.4/BA.5 Targeting Bivalent COVID-19 Vaccine

  9/28/2022

  Moderna, Inc. announced that the European Medicines Agency has accepted a variation for the evaluation of a 50 µg booster dose of the Omicron-containing bivalent COVID booster candidate, mRNA-1273.222 in adults 12 years and older.

• PolyPid Announces Eligibility for European Medicines Agency Centralized Procedure for D-PLEX₁₀₀ for the Prevention of Surgical Site Infections in Abdominal Surgery

  9/28/2022

  PolyPid Ltd. announced that it has received confirmation from the European Medicines Agency that D-PLEX100 is eligible for submission of a Marketing Authorization Application in the European Union under the Agency’s centralized procedure.