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
The European Commission (EC) has approved the label update of both Nilemdo (bempedoic acid) and Nustendi (bempedoic acid / ezetimibe fixed-dose combination (FDC)), as treatments for hypercholesterolaemia (high levels of cholesterol) and to reduce the risk of adverse cardiovascular events. 24 May 2024
The European Commission has presented European Union (EU) guidance on public procurement of medicines which is critical to improve the security of supply for patients and health systems. 24 May 2024
Swiss generic and biosimilar medicines company Sandoz today announced that the European Commission (EC) has granted marketing authorization for Wyost (denosumab) and Jubbonti (denosumab), the first and only biosimilar versions of reference medicines Xgeva and Prolia in Europe. 22 May 2024
The European Commission (EC) has decided not to adopt the European Medicines Agency’ human medicines committee CHMP's negative opinion of January 24, 2024 on the annual renewal of the conditional marketing authorization of Translarna (ataluren) and has returned the opinion to the CHMP for re-evaluation. 21 May 2024
At its meeting this week the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) reviewed medicines regarding their safety. 17 May 2024
Swedish Orphan Biovitrum has announced that the European Commission (EC) has approved an indication extension for Aspaveli (pegcetacoplan) to treat adults with paroxysmal nocturnal haemoglobinuria (PNH) who have hemolytic anemia. 8 May 2024
The European Medicines Agency’s (EMA) Emergency Task Force (ETF) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant JN.1 for the 2024/2025 vaccination campaign. 30 April 2024
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended five novel medicines for approval at its April 2024 meeting, as well as two biosimilars. 27 April 2024
The European Commission (EC) has approved tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use. 26 April 2024
San Diego, USA-based Travere Therapeutics and CSL Vifor today announced that the European Commission has granted conditional marketing authorization (CMA) for Filspari (sparsentan). 24 April 2024
A first-in-class treatment for paroxysmal nocturnal hemoglobinuria (PNH), Voydeya (danicopan), has been granted marketing authorization in Europe. 23 April 2024
Following a positive recommendation last month by the European Medicines Agency’s (EMA) human medicines committee (CHMP), today the European Commission (EC) granted marketing authorization for Emblaveo (aztreonam-avibactam) from Pfizer. 22 April 2024
The European Commission (EC) has granted marketing authorization for the interleukin (IL)-17A and IL-17F inhibitor Bimzelx (bimekizumab), from Belgian drugmaker UCB's, for the treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy. 22 April 2024
The European Commission (EC) has granted marketing authorization for Pyzchiva (biosimilar ustekinumab), said Swiss generics and biosimilars company Sandoz. 22 April 2024
The European Parliament has formally adopted new pharmaceutical legislation, including proposals for a new directive and a new regulation. 11 April 2024
A second Expert View piece from Xandra Neuberger, associate director, regulatory affairs and international service lead for clinical trial applications at PharmaLex. 4 April 2024
With new legislation on data protection in the offing, The European Federation of Pharmaceutical Industries and Associations (EFPIA) has called on negotiators to take more time to make sure the law is drafted optimally. 2 April 2024
Joint Clinical Assessments (JCA) can support getting new innovative cancer medicines to patients faster, if the right balance in evidence generation and assessment to facilitate national decisions on access for these innovations can be found. 2 April 2024