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
Following on from big-selling Herceptin (trastuzumab), Roche could have another big player in breast cancer, in the shape of its PD-L1 inhibitor Tecentriq (atezolizumab). 29 August 2019
The European Commission (EC) has approved the extension of the current marketing authorization of Solaris (eculizumab) to include the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease, making it the first and only drug cleared for this condition in Europe. 28 August 2019
The European Commission (EC) has now approved Empliciti (elotuzumab) plus pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with relapsed and refractory multiple myeloma (MM). 28 August 2019
Privately-held Swedish biotech OxThera today announced that, based on a positive opinion from the Pediatric Committee (PDCO), the European Medicines Agency has agreed to the proposed pediatric investigation plan (PIP) for Oxalobacter formigenes in the treatment of primary hyperoxaluria (PH). 23 August 2019
Relations between the US and European governments are generally not at their healthiest at present, but the way that their medicines regulators are spurring each other into improving standards provides a more encouraging picture. 19 August 2019
The Janssen and AbbVie partnered drug Imbruvica (ibrutinib) has now nabbed five European Commission (EC) approvals in as many years, as its use was broadened in two indications. 13 August 2019
Pharma major Sanofi announced European Union (EU) approval for an extension of the marketing authorization for Dupixent (dupilumab) to include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. 6 August 2019
The AstraZeneca type two diabetes drug Foxiga (dapagliflozin) has had its label updated for the European Union to include positive cardiovascular (CV) outcomes and renal data from the Phase III DECLARE-TIMI 58 trial. 5 August 2019
The European Commission has granted marketing authorization for Maviret (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to eight weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT)1, 2, 4, 5, and 6 infection. 2 August 2019
A European Commission (EC) approval means that GlaxoSmithKline’s Nucala (mepolizumab) is the only monthly anti-IL5 biologic approved in Europe that people with severe eosinophilic asthma can take at home, after a healthcare professional decides it is appropriate. 1 August 2019
A marketing authorization application (MAA) has been filed with the European Medicines Agency for the investigational, once-monthly, injectable cabotegravir, which will be used in combination with Janssen’s once-monthly, injectable rilpivirine to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine. 29 July 2019
Shares in ProQR Therapeutics looked set to open around 6% up on Monday with news that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) status to a drug in development for Leber’s congenital amaurosis 10 (LCA10). 29 July 2019
The European Medicines Agency (EMA) has recommended that Gilenya (fingolimod) must not be used by pregnant women or women able to have children who are not using effective contraception. 29 July 2019
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced on Friday that is has recommended extensions of use indications on eight currently approved medicines, as follows: 27 July 2019
The European Medicines Agency (EMA) has accepted a Type II Variation Application for regulatory review for the use of Xtandi (enzalutamide) in metastatic hormone-sensitive prostate cancer (mHSPC) patients. 24 July 2019
For our latest Special Report, Adriaan Fruijtier from CATS Consultants, gives an account of major talking points at one of the year’s major events in the calendar of the Regulatory Affairs Professionals Society (RAPS), which took place in Brussels earlier in the summer. 22 July 2019
Tthe European Commission (EC) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have granted the marketing authorization transfer to Netherlands-headquartered drugmaker Mylan for TOBI Podhaler and TOBI Solution in the UK for patients with cystic fibrosis. 22 July 2019
Johnson & Johnson’s pharma business Janssen has submitted to broaden the European label for Darzalex (daratumumab), for subcutaneous treatment of multiple myeloma. 19 July 2019
At the July meeting of the European regulator’s safety watchdog, the Pharmacovigilance Risk Assessment Committee (PRAC), new measures were agreed to avoid dosing errors related to methotrexate-containing medicines. 12 July 2019
Alexion Pharmaceuticals’ shares edged up almost 1% to $134.66 in after-hours trading on Wednesday, following the US drugmaker’s announcement that the European Commission had approved its rare blood disease drug Ultomiris (ravulizumab). 4 July 2019