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
As European drugmakers wrestle with regional lawmakers over proposed legislative changes, the industry has been emboldened by a German government report raising substantial concerns. 11 August 2023
UK pharma major AstraZeneca this morning revealed that Soliris (eculizumab) has been approved in the European Union (EU) for expanded use. 27 July 2023
The SGLT2 inhibitor drug Jardiance (empagliflozin), developed and marketed by family-owned German pharma major Boehringer Ingelheim and the USA’s Eli Lilly, has won approval from the European Commission for the new indication of chronic kidney disease (CKD). 25 July 2023
At its July meeting, the European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended three new biosimilars and rejected one application, as well as recommending 10 novel drugs. 21 July 2023
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended 10 novel medicines, as well as some biosimilars and indication extensions, for approval at its July 2023 meeting. 21 July 2023
Following the success of the European Medicines Agency’s OPEN initiative in dealing with vaccines and treatments regulation during the height of the COVID19 pandemic, the EMA has now expanded the scope of the scheme to a wider range of medicines. 21 July 2023
Not surprisingly given the negative opinion from the European Medicines Agency’s (EMA) human medicines committee (CHMP), the European Commission has followed guidance and has not granted marketing authorization for palovarotene, an investigational treatment for fibrodysplasia ossificans progressiva (FOP). 20 July 2023
The European Medicines Agency (EMA) has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of medicines. 19 July 2023
The European Medicines Agency (EMA) has accepted for review the marketing authorization application for bimekizumab, an interleukin (IL)-17A and IL-17F inhibitor, for the treatment of adults with moderate to severe hidradenitis suppurativa (HS), submitted by Belgium’s largest pharma company UCB. 18 July 2023
The European Medicines Agency (EMA) has accepted for regulatory review Astellas Pharma’s marketing authorization application (MAA) for zolbetuximab. 14 July 2023
Adding to US regulatory approval last month for its dual action antibody, Swiss pharma giant Roche today announced that the European Commission (EC) has granted conditional marketing authorization for Columvi (glofitamab) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. 11 July 2023
The safety monitoring committee of the European Medicines Agency is to investigate a potential connection between the use of certain Novo Nordisk products and suicidal thoughts. 11 July 2023
The European Medicines Agency (EMA), the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the extraordinary regulatory flexibilities for medicines put in place during the COVID-19 pandemic to help address regulatory and supply challenges arising from the pandemic. 7 July 2023
US protein-based vaccine developer Novavax saw its shares fall more than 4% to $7.06, despite announcing it has been granted full Marketing Authorization (MA) by the European Commission in the European Union (EU) for Nuvaxovid (NVX-CoV2373). 6 July 2023
Shares of US biotech Moderna, which is pioneering messenger RNA (mRNA) therapeutics and vaccines, edged up 1.5% to $123.54 yesterday, as it updated on regulatory submissions for mRNA-1345. 6 July 2023
The European Medicines Agency (EMA) is among the regulators to have endorsed a joint statement on the safety of COVID-19 vaccines issued by the International Coalition of Medicines Regulatory Authorities (ICMRA). 5 July 2023
The European Commission has granted approval for the label extension of Orkambi (lumacaftor/ivacaftor), from US biopharma firm Vertex Pharmaceuticals, for the treatment of children with cystic fibrosis (CF) ages 1 to 5 July 2023
Medicines for Europe, the trade body for generics and biosimilars companies in the region, has called for “a fair, cost-based approach” to regulatory fees. 30 June 2023
Cancer giant Bristol Myers Squibb has secured a new European approval for its checkpoint blocker Opdivo (nivolumab), in non-small cell lung cancer (NSCLC). 30 June 2023