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
At its June meeting, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) started a review of Zinbryta (daclizumab) used to treat adults with relapsing forms of multiple sclerosis. 10 June 2017
The European Commission has now granted marketing authorization for Refixia (nonacog beta pegol; N9-GP) for the treatment of adolescents and adults with hemophilia B. The authorization covers all 28 European Union member states. 7 June 2017
Amgen today announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration and a variation to the marketing authorization to the European Medicines Agency for Repatha (evolocumab), a PCSK9 inhibitor. 5 June 2017
The European Commission (EC) has approved Opdivo (nivolumab) for the treatment of locally-advanced unresectable or metastatic urothelial carcinoma (mUC) in adults after failure of prior platinum-containing therapy. 3 June 2017
The reality of a ‘hard Brexit’ – the UK leaving the European Union (EU) without a trade deal in place between the two parties – could lead to UK medicines being treated as imports by the EU and force drugmakers to set up some operations within member states. 2 June 2017
ViiV Healthcare has submitted applications for regulatory approval in Europe and the USA for a single-tablet, two-drug regimen combining its own dolutegravir with Janssen’s rilpivirine. 2 June 2017
US biotech Biogen’s Spinraza (nusinersen) has been approved in the European Union (EU) for the treatment of 5q spinal muscular atrophy (SMA). 1 June 2017
The European Commission has granted marketing authorization for Brineura (cerliponase alfa), the first treatment approved in the European Union for the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency. 1 June 2017
The European Commission has granted approval for Trumenba (meningococcal group B vaccine) for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) in individuals 10 years of age and older. 31 May 2017
Sandoz, a division of Swiss pharma giant Novartis, has had its proposed adalimumab and infliximab biosimilars accepted for regulatory review by the European Medicines Agency (EMA). 31 May 2017
In a report likely to please French and Scandinavian readers and have the opposite effect on Italians and Spaniards, the cities hoping to host the new headquarters of the European Medicines Agency (EMA) have been ranked by the financial services firm KPMG. 30 May 2017
Portugal's largest drugmaker Bial and Japanese pharma major Eisai have announced approval from the European Medicines Agency to market Zebinix (eslicarbazepine acetate) as a monotherapy to treat epilepsy. 23 May 2017
The European Medicines Agency has recommended changes to prescribing information for the antibiotic vancomycin to ensure appropriate use in the treatment of serious infections caused by Gram-positive bacteria. 22 May 2017
Swedish biotech firm Hansa Medical has been accepted onto the European Medicines Agency’s Priority Medicines (PRIME) scheme for lead candidate IdeS, an enzyme being developed to facilitate successful kidney transplantation. 19 May 2017
The European Medicines Agency’s 2016 annual report published today focuses on the Agency’s key achievements in the areas of medicine evaluation, support to research and development of new and innovative treatments and the safety monitoring of medicines in real life. 11 May 2017
Ireland has stepped up its bid to host the European Medicines Agency (EMA) with the official announcement being delivered and reiterated by Minister of Health, Simon Harris over the past week. 9 May 2017
A joint statement from bodies representing European pharmaceutical, biotech and biosimilar drugmakers has said that they welcome increased competition in the biologics markets. 5 May 2017
Denmark’s Genmab (OMX: GEN) said on Friday that the European Commission (EC) has granted a new marketing authorization for Darzalex (daratumumab. 29 April 2017
The share price of XBiotech plummeted by nearly 40% on Friday to $10.23 on news that the European Medicines Agency (EMA) had rendered a negative trend vote following discussions on the Day 180 List of Outstanding Issues related to the US biotech firm’s marketing authorization application (MAA) for Xilonix. 24 April 2017