European Medicines Agency (EMA)
7 Westferry Circus
Canary Wharf
London
E14 4HB
United Kingdom
Tel: 44-0-20-7523-7600
Website: http://www.ema.europa.eu/ema/
Email: info@ema.europa.eu
533 articles with European Medicines Agency (EMA)
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Pfizer Receives Positive CHMP Opinion for LORVIQUA® (lorlatinib) for Certain Adult Patients with Previously-Treated ALK-Positive Advanced Non-Small Cell Lung Cancer
3/1/2019
Pfizer announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for LORVIQUA®, an anaplastic lymphoma kinase tyrosine kinase inhibitor.
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Novo Nordisk files for a label update for Fiasp® to the EMA and the FDA seeking approval for use in children and adolescents
3/1/2019
Novo Nordisk announced that it recently submitted label updates to the European Medicines Agency and the US Food and Drug Administration for Fiasp® 100 u/mL, seeking approval for use as a new mealtime insulin for children and adolescents with type 1 diabetes.
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New Drug Landscape Dominated by High-cost Medicines
2/19/2019
The Patented Medicine Prices Review Board published the 2017 edition of Meds Entry Watch, an annual publication that provides the latest information on new medicines entering Canadian and international markets.
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As Britain’s plans to leave the European Union—Brexit—stagger toward the March 29 deadline, the UK biopharma industry is taking stock of the likely impact.
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European Medicines Agency Adopts Positive Opinion for Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy for First-Line Treatment of Adults with Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
2/4/2019
Recommendation Based on Significant Overall Survival Benefit Demonstrated with KEYTRUDA in Combination with Chemotherapy in Pivotal KEYNOTE-407 Trial
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EMA Grants Orphan Drug Designation to TLC178 for the Treatment of Soft Tissue Sarcoma
1/22/2019
Taiwan Liposome Company, Ltd. today announced that the European Medicines Agency (EMA) has granted orphan drug designation for TLC178 for the treatment of soft tissue sarcoma.
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European Medicines Agency Accepts Extension Marketing Authorisation Application for Review of Celltrion's Remsima SC, the Subcutaneous Version of Remsima®
12/3/2018
European Medicines Agency started to officially review ‘Remsima SC’; expecting European approval in the second half of next year
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The UK’s exit from the European Union, Brexit, will impact numerous industries in the UK and Europe, but the biopharma industry has its own unique challenges.
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Janssen receives positive CHMP opinion for ERLEADA™ (apalutamide) for patients with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease
11/16/2018
Approval is based on Phase 3 SPARTAN clinical study data which showed apalutamide decreased the risk of distant metastasis or death by 72 percent and improved median metastasis-free survival by more than two years
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Modis Therapeutics Announces PRIME Designation Granted by the European Medicines Agency to MT1621 for the Treatment of TK2 Deficiency
11/13/2018
Modis Therapeutics announced today that the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) designation to MT1621, Modis' investigational treatment for patients with thymidine kinase 2 deficiency (TK2d).
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Viagra and Cialis: PDE-5 Inhibitors May Have Broader Applications in Cancer, Neurology and Cardio...
11/13/2018
Viagra (sildenafil), Pfizer’s blockbuster drug for erectile dysfunction, is a classic example of how a drug developed for one thing can turn out to be successful for another. -
EMA Validates and Grants Accelerated Assessment of Marketing Authorization Application for Daiichi Sankyo's FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
11/5/2018
Application based on results of pivotal phase 3 QuANTUM-R study of quizartinib in patients with relapsed/refractory FLT3-ITD AML
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An FDA advisory committee overwhelmingly votes in support of Sage's post-partum depression drug, clearing the way for regulatory approval.
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Days after Novartis axed one-fifth of its research programs, the Swiss pharma giant said it intends to seek regulatory approval for 60 new treatments between 2019 and 2021.
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Although there is some slowdown as the FDA moves into the holiday season in late November and into December, there are still upcoming target action dates. Here’s a look at this week’s PDUFA dates.
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Biopharma companies set to release financial reports next week have reported positive news in recent months.
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Merck’s blockbuster anti-PD-1 therapy Keytruda has snagged another regulatory approval from the U.S. Food and Drug Administration. The checkpoint inhibitor has been approved, in combination with chemotherapy, as a first-line treatment for patients with metastatic squamous non-small cell lung cancer.
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As we end October and head into November, the Food and Drug Administration (FDA) continues its work. This upcoming week has several PDUFA action dates for drug applications. Here’s a look.
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This week will have moderate activity by the U.S. Food and Drug Administration (FDA). Although they jumped the gun on Regeneron and Sanofi’s cancer drug, there are still plenty of other decisions being made this week. Here’s a look.
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Part of the Trump Administration and the U.S. Food and Drug Administration (FDA)’s strategy to push down drug prices is to develop ways to increase competition. As such, the agency launched a Drug Competition Action Plan that has several components.