Merck KGaA today said that the European Medicines Agency has accepted for review the Marketing Authorization Application (MAA) of the investigational product cladribine tablets for the treatment of relapsing-remitting multiple sclerosis (MS). 18 July 2016
As European Union member states vie to get re-location of the European Medicines Agency to their country following the UK referendum vote to leave the EU, Spain being the latest to pitch its case, the EMA acknowledges the outcome and says it is now up to the UK government to decide how to act. 7 July 2016
AbbVie’s Humira (adalimumab) has today received approval from the European Medicines Agency as the first and only biologic medicine authorized for patients with certain types of non-infectious uveitis, an inflammatory, painful eye condition that can lead to blindness. 5 July 2016
USA-based Puma Biotechnology said today that it has submitted its Marketing Authorization Application to the European Medicines Agency for neratinib. 27 June 2016
While the exit of the UK from the European Union undoubtedly creates significant issues for the UK pharmaceutical and medical device industries in ensuring highly regulated European markets remain open to business, opportunities remain for these sectors to thrive. 27 June 2016
At its June meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of six new medicines, including one advanced therapy medicinal product (ATMP). 25 June 2016
USA-based drug manufacturer and contract development firm Pharmaceutics International is now the subject of a European Medicines Agency review into alleged failures to adhere to good manufacturing practice (GMP) at its UK site. 24 June 2016
The European Ombudsman, Emily O'Reilly, has welcomed increased transparency in the clinical testing of Humira (adalimumab), one of the world’s biggest selling drugs, following her inquiry into the publication of clinical study reports. 10 June 2016
The European Medicines Agency (EMA) has accepted aducanumab, an investigational treatment for early Alzheimer’s disease being developed by US biotech major Biogen, into its Priority Medicines (PRIME) program. 2 June 2016
The European Medicines Agency started a review of the guidelines that describe first-in-human clinical trials and the data needed to enable their appropriate design and allow initiation. This is being done in cooperation with the European Commission and the Member States of the European Union. 27 May 2016
The European Medicines Agency has recommended the granting of marketing authorizations in the European Union for two new combination therapies against chronic (long-term) hepatitis C virus (HCV) infection, Epclusa (sofosbuvir/velpatasvir) and Zepatier (grazoprevir/elbasvir). 27 May 2016
Sandoz, Swiss pharma giant Novartis' generics and biosimilars business, says that the European Medicines Agency has accepted its Marketing Authorization Application for a biosimilar to Roche's blockbuster drug MabThera (rituximab). 24 May 2016
The European Medicines Agency has published a report summarizing the experience with its small and medium-sized enterprise (SME) initiative over the last 10 years. 12 May 2016
A new scheme which aims to accelerate the development and approval of new medicines in areas of unmet medical need in Europe attracted 18 applications in its first month, it has been revealed. 5 May 2016
In April, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) started a new safety review and extended the scope of an ongoing review procedure. 15 April 2016
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines, including one advanced therapy medicinal product (ATMP), for approval at its March meeting. 2 April 2016
The European Medicines Agency has, at the request of the European Commission, started a review of the cancer medicine Zydelig (idelalisib), following concerns over serious adverse events in ongoing clinical trials. 12 March 2016
Patients are promised earlier access to new drugs which are showing potential, following the launch of a new scheme on Monday by the European Medicines Agency (EMA). 7 March 2016
Belgian biopharmaceutical company TiGenix has submitted a centralized Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its lead product Cx601, it has been announced. 3 March 2016
Baxalta has submitted a Marketing Authorization Application to the European Medicines Agency for approval of Adynovi, an extended circulating half-life recombinant Factor VIII (rFVIII) treatment. 3 March 2016
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