The European Commission has granted the Marketing Authorization for Ajovy (fremanezumab) 225mg solution for injection in pre-filled syringe for the prophylaxis of migraine in adults who have at least four migraine days per month. 1 April 2019
The European Medicines Agency (EMA) has accepted a Marketing Authorization Line Extension Application for subcutaneous (SC) Entyvio (vedolizumab) for maintenance therapy in moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD). 1 April 2019
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) submission for cefiderocol from Shionogi. 1 April 2019
The March 25-28 2019 meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) was held for the first time in its new post-Brexit offices in Amsterdam, Netherlands, but came back with only recommendations for one new initial marketing authorization and just three extensions of indication. 29 March 2019
New research highlights the continued differences between the USA and European to drug approval, and the need for a global approach, to drug development to ensure success across both continents. 27 March 2019
AstraZeneca’s Forxiga (dapagliflozin) has become the first oral medicine approved in Europe as an adjunct to insulin for adults with type-1 diabetes. 25 March 2019
Janssen Pharmaceutica has submitted a Type II variation application to the European Medicines Agency (EMA) for a combination therapy for multiple myeloma. 22 March 2019
The European Medicines Agency is advising healthcare professionals and patients not to exceed the recommended dose of Xeljanz (tofacitinib) when treating rheumatoid arthritis (RA). 22 March 2019
Privately-held German firm Boehringer Ingelheim has filed to broaden the label for Ofev (nintedanib), to include patients with systemic sclerosis associated interstitial lung disease (SSc-ILD), also known as scleroderma. 18 March 2019
The European Commission (EC) has approved a new indication for Praluent (alirocumab), to reduce cardiovascular (CV) risk in adults with established atherosclerotic CV disease (ASCVD) by lowering low-density lipoprotein cholesterol (LDL-C) levels as an adjunct to correction of other risk factors. 18 March 2019
The European Medicines agency has started a review of medicines containing fluorouracil (also known as 5-fluorouracil or 5-FU) and the related medicines capecitabine, tegafur and flucytosine, which are converted to fluorouracil in the body. The review will examine existing screening methods and their value in identifying patients at increased risk of severe side effects. 15 March 2019
The European Medicines Agency has granted approval for Roche to market MabThera (rituximab) against a rare condition, pemphigus vulgaris (PV). 15 March 2019
New Jersey, USA-based Merck & Co has picked up another approval in Europe for Keytruda (pembrolizumab), in combination with chemo, for the first-line treatment of squamous non-small cell lung cancer (NSCLC). 14 March 2019
Roche’s Hemlibra (emicizumab) has been approved for the prevention of bleeding episodes in people with severe hemophilia A without factor VIII inhibitors in the European Union (EU). 14 March 2019
Switzerland’s Roche has won European approval for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) plus chemo, for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC). 8 March 2019
Research shows some 79% of the American public view the cost of prescription drugs as unreasonable, and lawmakers and regulators are increasingly convinced the industry charges too much for its products. 8 March 2019
Finnish drugmaker Orion Corp and Germany’s Bayer have filed a marketing authorization applications with the European Medicines Agency for their jointly-developed darolutamide for the treatment of patients with non-metastatic castration resistant prostate cancer (nmCRPC). 8 March 2019
At its last meeting in London before moving to new headquarters in Amsterdam as a result of Brexit, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) made positive recommendations for the approval of seven novel medicines. 1 March 2019
Japanese drug major Astellas Pharma says its marketing authorization application (MAA) for the oral once-daily therapy Xospata (gilteritinib) for the treatment of adult patients who have relapsed or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation (FLT3mut+) has been accepted by the European Medicines Agency for regulatory review. 28 February 2019
The European Medicines Agency’s pharmacovigilance committee, PRAC, has started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviors. 4 October 2024
The European Medicines Agency (EMA) and the European medicines regulatory network are working to speed up the approval of new medicines. 3 October 2024
Following a positive a positive European Medicines Agency recommendation in July, the European Commission (EC) has now approved Yuvanci (macitentan 10mg and tadalafil 40mg single tablet combination therapy [M/T STCT]). 1 October 2024
Shanghai-based Junshi Biosciences has announced that the European Commission has approved Loqtorzi (toripalimab) for two cancer indications. 26 September 2024
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Hetronifly (serplulimab). 23 September 2024
The European Commission has conditionally approved the marketing application submitted by Ipsen for Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) 21 September 2024
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) recommended approval of five novel medicines at its September meeting 20 September 2024
The European Medicines Agency’s (EMA) advisory committee the CHMP has adopted a positive opinion for a label update of Danish drugmaker Novo Nordisk’s Wegovy (semaglutide 2.4mg). 20 September 2024
The European Medicines Agency’s (EMA) safety committee (PRAC) has recommended measures to minimize serious outcomes of agranulocytosis, a known side effect caused by the painkiller metamizole. 7 September 2024
EC approved Keytruda (pembrolizumab), Merck & Co’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for urothelial carcinoma in adults. 3 September 2024
Pierre Fabre Laboratories has announced that the European Commission (EC) has approved Braftovi (encorafenib) in combination with Mektovi (binimetinib) for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with a BRAFV600E mutation. 30 August 2024
The European Commission has authorized GSK's (LSE: GSK) Arexvy (respiratory syncytial virus vaccine) for preventing lower respiratory tract disease caused by RSV in adults aged 50-59 with underlying health conditions. 30 August 2024
The European Commission (EC) has extended the indications of the antifungal Cresemba (isavuconazole) to pediatric patients, says Swiss drugmaker Basilea Pharmaceutica. 28 August 2024
The European Commission (EC) has approved a Type II extension of indication for Johnson & Johnson’s Rybrevant (amivantamab) in combination with chemotherapy (carboplatin and pemetrexed). 27 August 2024
The European Commission has approved PiaSky (crovalimab), a novel recycling monoclonal antibody that inhibits the complement protein C5, from Swiss pharma giant Roche. 27 August 2024
US biotech Regeneron Pharmaceuticals yesterday announced that the European Commission (EC) has approved Ordspono (odronextamab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. 27 August 2024
South Korea’s Celltrion yesterday announced the European Commission (EC) approval for the use of SteQeyma (CT-P43), an ustekinumab biosimilar referencing Stelara, for the treatment of multiple chronic inflammatory diseases. 27 August 2024
Italian ophthalmics company SIFI SpA says that the European Commission has approved Akantior (polihexanide) for the treatment of acanthamoeba keratitis (AK) 27 August 2024