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
The European Federation of Pharmaceutical Industries and Associations (EFPIA) noted in a posting on its website that European Union legislation will shape the future pf research, development and manufacturing in Europe for decades to come. 8 July 2024
The European Medicines Agency (EMA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for certain adults with uncontrolled chronic obstructive pulmonary disease (COPD). 3 July 2024
Pierre Fabre revealed that the European Commission (EC) has authorized the marketing of its Obgemsa (vibegron) for the symptomatic treatment of overactive bladder syndrome in adults. 2 July 2024
Specialty vaccine company Valneva has announced that the European Commission (EC) has granted marketing authorization for its single-dose vaccine, Ixchig, for the prevention of disease caused by the chikungunya virus in people aged 18 years of and older. 1 July 2024
AstraZeneca’s Marketing Authorization Application (MAA) for sipavibart has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for the pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised patients. 1 July 2024
Johnson & Johnson (NYSE: JNJ) has received a new European approval for a combination of Rybrevant (amivantamab) plus chemotherapy in lung cancer. 28 June 2024
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended seven novel medicines and one biosimilar for approval at its June 2024 meeting. 28 June 2024
Swiss pharma giant Roche has announced that the European Commission has granted marketing authorization for Ocrevus (ocrelizumab) subcutaneous (SC) to treat relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). 25 June 2024
As anticipated following a positive scientific opinion, British pharma major AstraZeneca's Truqap (capivasertib) has been approved by the European Union. 20 June 2024
The European Commission has granted marketing authorization for Altuvoct (efanesoctocog alfa), for the treatment and prevention of bleeds and perioperative prophylaxis in hemophilia A. 19 June 2024
In Europe, revised rules for the Clinical Trials Information System (CTIS) are now applicable, offering faster access to clinical trial information. 18 June 2024
At its June meeting, the European Medicines Agency’s (EMA) pharmacovigilance committee, PRAC, came to the conclusion that patients treated with CAR T-cell medicines should be monitored life-long for secondary malignancies. 14 June 2024
In a blog post, the general counsel of European trade group EFPIA - the European Federation of Pharmaceutical Industries and Associations - has argued for effective incentives to be included in the EU general pharmaceutical legislation. 10 June 2024
A report from industry analyst GlobalData finds that reforms to the European Union's general pharmaceutical legislation have become a pivotal policy development for the pharma industry. 6 June 2024
Italy’s Philogen and Indian drugmaker Sun Pharmaceutical Industries have submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the approval of Nidlegy (daromun). 5 June 2024
Danish allergy immunotherapy specialist ALK Abell today revealed that its European regulatory filing for Itulazax (tree sublingual allergy immunotherapy [SLIT] tablet) in young children has been accepted for review by the relevant health authorities. 30 May 2024