Days after revealing positive Phase III data for its latest cystic fibrosis candidate, Vertex Pharmaceuticals gave investors more good news on Thursday, in the form of a new European approval for Kalydeco (ivacaftor). 29 November 2018
Following a positive recommendation from the European Medicines Agency’ advisory committee in September, the European Commission has now officially approved Delstrigo and Pifeltro for the treatment of HIV-1 infection. 29 November 2018
Swiss pharma giant Novartis got a boost this morning, with an added indication for its blockbuster multiple sclerosis drug, lifting its share price by 1.18% to 89.24 Swiss francs late morning. 29 November 2018
The European Commission granted marketing authorization for Alunbrig (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. 28 November 2018
The European Commission has granted a marketing authorization to Poteligeo (mogamulizumab), a humanized monoclonal antibody (MAb) directed against CC chemokine receptor 4 (CCR4), for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy. 26 November 2018
The European Court of Justice will not stand in the way of Roche’s cancer drug Avastin (bevacizumab) being prescribed for an unlicensed indication. 23 November 2018
The Mundipharma network of independent associated companies today announced that the European Commission (EC) has granted approval for the use of Pelmeg (pegfilgrastim). 23 November 2018
Switzerland-based Novartis has won European approval for the one-time gene therapy Luxturna (voretigene neparvovec). The treatment was approved in the USA in late December 2017. 23 November 2018
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended fexinidazole, the first all-oral treatment for sleeping sickness. 22 November 2018
Swedish drugmaker Camurus (STO: CAMX) today said that the European Commission has granted marketing authorization for Buvidal (CAM2038), with news of the approval sending the firm’s shares soaring 9.38% to 89.80 Swedish kronor. 22 November 2018
As expected, following a positive recommendation from its advisory panel in September, the European Medicines Agency has granted approval for Emgality (galcanezumab), in the treatment of migraines. 19 November 2018
Admitting that its trial results are not strong enough, Roche has told the European Medicines Agency (EMA) not to consider a type II variation to extend the use of Tecentriq (atezolizumab) in combination with Avastin (bevacizumab). 19 November 2018
The European Medicines Agency’s Committee for Products for Human Use (CHMP) recommended four medicines for approval, including one for use in countries outside the European Union, at its November 2018 meeting, as well as two re-examinations and four indication extensions. 16 November 2018
The European Commission yesterday released the results of a new Eurobarometer study on the public knowledge on antibiotics and overall trends in their use ahead of the 11th European Antibiotic Awareness Day. 16 November 2018
The European Medicines Agency has published the new good pharmacovigilance practice (GVP) chapter IV on specific considerations for the pediatric population. 14 November 2018
California, USA-based Modis Therapeutics announced today that the European Medicines Agency has granted PRIME (PRIority MEdicines) designation to MT1621, Modis' investigational treatment for patients with thymidine kinase 2 deficiency (TK2d). 13 November 2018
Japanese pharma major Daiichi Sankyo says that the European Medicines Agency has validated for review and granted accelerated assessment to the Marketing Authorization Application (MAA) for quizartinib for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) which is FLT3-ITD positive. 6 November 2018
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