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
Already expected to reach blockbuster status with its 2022 sales, AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has won another approval in Europe. 26 January 2023
The European Medicines Agency is to review a regulatory submission from Swiss gene editing specialist CRISPR Therapeutics and partner Vertex Pharmaceutical. 25 January 2023
The European Commission Decision Reliance Procedure (ECDRP) has been extended to December 31, 2023, when a new international recognition framework will be in place, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced today. 24 January 2023
The European Medicines Agency has validated a regulatory submission for arpraziquantel, a potential new treatment for schistosomiasis in young children. 23 January 2023
Shortages of antibiotics have been seen across the globe a surge in bacterial infections after countries lifted pandemic restrictions. Of the 35 countries whose data is collected by the World Health Organization (WHO), 80% have some form of shortage of amoxicillin-related antibiotics. 20 January 2023
Fatal cases of acute liver failure reported in patients treated with Zolgensma (onasemnogene abeparvovec) were raised this week at the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC). 13 January 2023
A marketing authorization submission for talquetamab - an immunotherapy with the potential to shake up the multiple myeloma market - is now sat on regulators’ desks at the European Medicines Agency. 3 January 2023
UK pharma major AstraZeneca today announced two approvals from the European Commission for expanded indications for its blockbuster cancer drugs, one for Imfinzi (durvalumab) and the other for Lynparza (olaparib). 21 December 2022
The European Commission (EC) has granted conditional marketing authorization for the use of Zynlonta (loncastuximab tesirine) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), Swedish Orphan Biovitrum, also known as Sobi, and Switzerland’s ADC Therapeutics announced today. 21 December 2022
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published recommendations that aim to facilitate the conduct of decentralized clinical trials (DCTs). 20 December 2022
The European Commission (EC) has granted marketing authorization for Ebvallo (tabelecleucel)vas a monotherapy for treatment of adult and pediatric patients two years of age and older with relapsed or refractory Epstein Barr virus positive post transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. 19 December 2022
The European Medicines Agency’s human medicines committee (CHMP) recommended four novel medicines for approval at its December 2022 meeting. A final approval decision from the European Commission can be expected within the next two or three months. 16 December 2022
The European Commission has granted marketing authorization for Livmarli (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) aged two months and older. 15 December 2022
Adding to a string of approved indications for the interleukin (IL) and IL-4 blocking antibody, the European Commission (EC) has expanded the marketing authorization for Dupixent (dupilumab) in the European Union to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. 15 December 2022
As anticipated, following a positive decision from its scientific committee, the European Medicines Agency has granted marketing authorization for Pluvicto (vipivotide tetraxetan). 14 December 2022
The marketing authorization application (MAA) for momelotinib, an investigational oral treatment for myelofibrosis, submitted by UK pharma major GSK, has been accepted by the European Medicines Agency (EMA). 7 December 2022
Following a review, the European Medicines Agency’s (EMA) Emergency Task Force (ETF) has concluded that adapted mRNA bivalent vaccines targeting the original strain and Omicron BA.4-5 subvariants of SARS-CoV-2 may be used for initial vaccination. 7 December 2022
The European Medicines Agency (EMA) has accepted for review the marketing authorization application (MAA) for aumolertinib, a third-generation epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI). 2 December 2022