European Medicines Agency (EMA)

782 articles with European Medicines Agency (EMA)

• 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.

• WuXi Biologics' Drug Substance and Drug Product Facilities Again Approved by U.S. FDA and EMA

  9/20/2022

  WuXi Biologics announced that its two Drug Substance facilities and a Drug Product facility located in Wuxi city received regulatory approvals from the European Medicines Agency and the U.S. Food and Drug Administration.

• AbbVie Secures Positive CHMP Opinion for Risankizumab (SKYRIZI®) for the Treatment of Adults with Moderate to Severe Crohn's Disease

  9/19/2022

  AbbVie announced the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending the approval of risankizumab for the treatment of adults with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.

• Press Release: CHMP recommends approval of Beyfortus® (nirsevimab) for prevention of RSV disease in infants

  9/16/2022

  The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for Beyfortus® for the prevention of respiratory syncytial virus lower respiratory tract disease in newborns and infants during their first RSV season.

• Agios Receives Positive CHMP Opinion for PYRUKYND® (mitapivat) for the Treatment of Pyruvate Kinase (PK) Deficiency in Adult Patients

  9/16/2022

  Agios Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion on September 15, 2022, recommending the granting of a marketing authorization for PYRUKYND® for the treatment of pyruvate kinase deficiency in adult patients.

• Sensorion Receives Positive Opinion for Orphan Drug Designation for OTOF-GT for the Treatment of Otoferlin Gene-Mediated Hearing Loss From the European Medicine Agency

  9/12/2022

  Sensorion announces that the European Medicines Agency Committee for Orphan Medicinal Products has adopted a positive opinion on Sensorion’s application for Orphan Drug Designation for its lead therapy gene candidate, OTOF-GT, a gene therapy intended for the treatment of otoferlin gene mediated hearing loss.

• FDA and EMA Accept Regulatory Submission for Pfizer’s Ritlecitinib for Individuals 12 Years and Older with Alopecia Areata

  9/9/2022

  Pfizer Inc. announced that the U.S. Food and Drug Administration accepted for filing the New Drug Application for ritlecitinib for adults and adolescents 12 years of age and older with alopecia areata.

• EMA Committee for Medicinal Products for Human Use (CHMP) Adopts Positive Opinion Recommending Authorization for the Use of Moderna's Omicron-Targeting Bivalent Booster in the European Union

  9/1/2022

  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 Spikevax bivalent Original/Omicron BA.1, the company's next-generation bivalent vaccine candidate that contains mRNA-1273 and a vaccine candidate targeting the Omicron variant of concern.

• Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5 Adapted Bivalent Vaccine

  8/26/2022

  Pfizer Inc. and BioNTech SE announced they have completed a submission to the European Medicines Agency for a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older.

• Pfizer and BioNTech Announce Updated COVID-19 Vaccine Data Supporting Efficacy in Children 6 Months through 4 Years of Age

  8/23/2022

  Pfizer Inc. and BioNTech SE announced updated efficacy results from a Phase 2/3 trial evaluating a three 3-µg dose series of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age, reinforcing previously reported interim vaccine efficacy data collected in March and April 2022.

• European Medicines Agency Commences Review of Oral Fixed-Dose Combination of Decitabine and Cedazuridine for the Treatment of Adults with Acute Myeloid Leukemia

  8/22/2022

  Astex Pharmaceuticals, Inc. announce that the European Medicines Agency has accepted the Marketing Authorisation Application for the oral fixed-dose combination of decitabine and cedazuridine for the initial treatment of adults with acute myeloid leukemia who are not candidates for standard induction chemotherapy.

• Menarini Group's Elacestrant Marketing Authorization Application Accepted for Review by the European Medicines Agency (EMA) for the Treatment of ER+/HER2- Advanced or Metastatic Breast Cancer

  8/19/2022

  The Menarini Group, a privately held Italian pharmaceutical and diagnostics company, and Stemline Therapeutics, a wholly-owned subsidiary of the Menarini Group, announced that EMA has validated the Marketing Authorization Application for elacestrant, a selective estrogen receptor degrader, for patients with ER+/HER2- advanced or metastatic breast cancer.

• Calliditas Therapeutics: Interim Report Q2, 2022

  8/18/2022

  On May 19th, the European Medicines Agency announced that it had adopted a positive opinion regarding the application for conditional approval of Kinpeygo® for the treatment of IgA nephropathy, and on July 15th the European Commission issued the market authorization for Kinpeygo in the European Economic Area.

• Pharming Group Receives Accelerated Assessment in Europe for leniolisib for the Treatment of Rare Immunodeficiency, APDS

  8/1/2022

  Pharming Group N.V. announces that the European Medicines Agency's Committee for Medicinal Products for Human Use has granted an accelerated assessment for the Marketing Authorisation Application for leniolisib.

• Brand Institute's Head of European Regulatory Affairs Discusses the EMA's Upcoming NRG Meeting Calendar

  8/1/2022

  Brand Institute, the global leader in pharmaceutical and healthcare-related name development, is pleased to share the Name Review Group meeting dates and respective submission deadlines, as announced by the European Medicines Agency.

• Matinas BioPharma Announces Positive Opinion by the European Medicines Agency on Orphan Drug Designation for MAT2203 for the Treatment of Cryptococcosis

  7/25/2022

  Matinas BioPharma announced that the European Medicines Agency Committee for Orphan Medicinal Products has adopted a positive opinion recommending MAT2203 for designation as an orphan medicinal product for the treatment of cryptococcosis.

• Aurinia Announces Positive CHMP Opinion for LUPKYNIS® (voclosporin) for the Treatment of Adults with Active Lupus Nephritis in Europe

  7/22/2022

  Aurinia Pharmaceuticals Inc. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending voclosporin for marketing authorization to treat adults with active lupus nephritis, a serious complication of systemic lupus erythematosus.