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
There will be changes impacting drugmakers doing business in Northern Ireland as a result of February’s Windsor Framework agreement between the UK and European Union (EU). 7 March 2023
The European Commission (EC) has granted full Marketing Authorization for Reblozyl (luspatercept), for treatment in adult patients of anemia associated with non-transfusion-dependent (NTD) beta thalassemia, US pharma major Bristol Myers Squibb announced on Friday. 4 March 2023
The European Commission has granted marketing authorization for Nubeqa (darolutamide) alongside androgen deprivation therapy in combination with docetaxel, to treat metastatic hormone-sensitive prostate cancer (mHSPC). 1 March 2023
The European Medicines Agency’s human medicines committee, the CHMP, on Friday recommended the refusal of a marketing authorization for US pharma giant Merck & Co’s Lagevrio (molnupiravir) for the treatment of COVID-19 in adults. 27 February 2023
At its February meeting, the European Medicines Agency’s human medicines committee CHMP recommended approval of eight novel medicines, one of which is a biosimilar. 24 February 2023
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for Pfizer’s respiratory syncytial virus (RSV) vaccine candidate. 22 February 2023
UK pharma major AstraZeneca today revealed that Imfinzi (durvalumab) and Imjudo (tremelimumab) immunotherapy combinations have been approved in the European Union (EU) for the treatment of advanced liver and lung cancers. 22 February 2023
Global specialist HIV company ViiV Healthcare, which is majority owned by GSK, has been granted marketing authorization by the European Medicines Agency (EMA) for Triumeq PD. 22 February 2023
The European Commission has granted conditional marketing authorization (CMA) for Hemgenix (etranacogene dezaparvovec), the first and only one-time gene therapy for the treatment of severe and moderately severe hemophilia B (congenital Factor IX deficiency) in adults without a history of Factor IX inhibitors. 21 February 2023
Dutch rare disease specialist Pharming has suffered a setback in the European approval process for its leniolisib, a treatment for activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency. 16 February 2023
Icelandic firm Alvotech and marketing partner German drugmaker STADA Arzneimittel today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT04, Alvotech’s proposed biosimilar to Stelara (ustekinumab). 9 February 2023
Britain’s AstraZeneca has secured a new European approval for heart med Forxiga (dapagliflozin), an innovative medicine known in the USA as Farxiga. 8 February 2023
Belgian drug major UCB’s shares were up 2% at 77.70 euros this morning, on the news that Fintepla (fenfluramine) oral solution has been approved by the European Commission for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) as an add-on therapy to other anti-epileptic medicines for patients two years of age and older. 8 February 2023
Pharma lobby group the European Federation of Pharmaceutical Industries and Associations (EFPIA) says it welcomes the opportunity to provide feedback on the European Commission proposal for a revised European Medicines Agency (EMA) Fees regulation. 7 February 2023
The European Medicines Agency (EMA), along with the Heads of Medicines Agencies (HMA) and the European Commission (EC) announced on Friday that they are launching a public consultation on the establishment of a multi-stakeholder platform to improve clinical trials in the European Union (EU). 6 February 2023
Today (January 31) marks the start of the mandatory application of the Clinical Trials Regulation for all new clinical trials. It is a significant milestone in the transformation of the oversight and management of clinical trials in the European Union. 31 January 2023
Adding yet another indication for Sanofi (Euronext: SAN) and Regeneron’s (Nasdaq: REGN) blockbuster interleukin (IL)-13 and IL-4 blocking antibody Dupixent (dupilumab), the European Commission (EC) has expanded the marketing authorization to treat eosinophilic esophagitis (EoE). 30 January 2023
The European Medicines Agency (EMA) has issued an update on ongoing shortages of antibiotic medicines containing amoxicillin—alone and in combination with clavulanic acid. 27 January 2023
Although there were several positive recommendations for label extensions on already approved medicines, January proved a thin month for novel drug approvals in the European Union, with just one new drug and three for generics. 27 January 2023