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
Sino-American biotech BeiGene today announced that it has entered into an agreement with Novartis to regain worldwide rights to develop, manufacture, and commercialize Tevimbra (tislelizumab). 19 September 2023
The European Commission (EC) has become the third medicines regulator to grant marketing authorization for Litfulo (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe alopecia areata. 19 September 2023
The European Commission (EC) has approved Otsuka Pharmaceutical and its subsidiary Astex Pharmaceuticals’ Inaqovi (oral decitabine and cedazuridine) as monotherapy for the treatment of adults with newly-diagnosed acute myeloid leukemia (AML) who are ineligible for standard induction chemotherapy. 19 September 2023
A cancer drug under development by Cellectar Biosciences, a company based in New Jersey, USA, has been awarded an expedited review framework from the European Medicines Agency. 19 September 2023
Significant changes to the way European health technology assessments (HTA) take place is underway, with a transitional period set to be in force for several years. 18 September 2023
Following its September 2023 meeting, the European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended approval of six novel medicines. 15 September 2023
The European Medicines Agency (EMA) has validated Japanese pharma major Astellas Pharma’s Type II variation for Xtandi (enzalutamide) for the treatment of patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC). 13 September 2023
Italy’s privately-held drug developer Italfarmaco Group today revealed that its Marketing Authorization Application (MAA) for Givinostat as a potential treatment for Duchenne muscular dystrophy (DMD) has been submitted to the European Medicine Agency. 5 September 2023
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommends new measures to avoid exposure of children to topiramate-containing medicines in the womb, because the medicine may increase the risk of neurodevelopmental problems after exposure during pregnancy. 4 September 2023
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended authorizing a version of BioNTech and Pfizer’s Comirnaty COVID-19 vaccine targeting the Omicron XBB.1.5 subvariant. 30 August 2023
The European Commission (EC) has approved the extension of the Evrysdi (risdiplam) European Union (EU) marketing authorization to include infants with a clinical diagnosis of spinal muscular atrophy (SMA) type one, type two or type three or with one to four SMN2 copies from birth to below two months. 29 August 2023
New York-based pharma giant Pfizer has secured a European approval for Abrysvo, an innovative vaccine to prevent infection with respiratory syncytial virus (RSV). 25 August 2023
The European Commission (EC) has granted conditional marketing authorization (CMA) of Talvey (talquetamab), developed by Janssen Pharmaceuticals. 22 August 2023
The European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for Danish dermatology specialist LEO Pharma’s delgocitinib cream. 18 August 2023
US healthcare giant Johnson & Johnson subsidiary Janssen today revealed that the European Commission (EC) has granted the approval of a Type II variation application for Tecvayli (teclistamab). 18 August 2023
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) submitted by US biotech Regeneron Pharmaceuticals for its odronextamab. 18 August 2023
The European Medicines Agency (EMA) has accepted for regulatory review the marketing authorization application (MAA) for avacincaptad pegol (ACP), an investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), Astellas Pharma announced today. 18 August 2023
US drugmaker AbbVie has won approval from the European Commission (EC) for Aquipta (atogepant) for the prophylaxis of migraine in adults who have four or more migraine days per month. 17 August 2023