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 Commission (EC) has approved Sanofi’s Xenpozyme (olipudase alfa) as the first and only enzyme replacement therapy to treat non-central nervous system (CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in pediatric and adult patients with ASMD type A/B or ASMD type B. 28 June 2022
The European Commission (EC) has approved its CAR-T cell therapy Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy. 28 June 2022
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has started a review of data to extend the use of the smallpox vaccine Imvanex to include protecting people from monkeypox disease. 28 June 2022
The European Commission has granted marketing authorization for Nexviadyme (avalglucosidase alfa), an enzyme replacement therapy (ERT) for the long-term treatment of both late-onset and infantile-onset Pompe disease, a rare, progressive and debilitating muscle disorder, from French pharma major Sanofi. 28 June 2022
Leading PARP blocker Lynparza (olaparib) looks set to secure a new marketing authorization in Europe, after a positive scientific opinion. 27 June 2022
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of its bevacizumab biosimilar referencing Avastin, Vegzelma (CT-P16), from South Korea-headquartered Celltrion Healthcare. 25 June 2022
The European Medicines Agency’s human medicines committee (CHMP) recommended seven novel medicines for approval at its June 2022 meeting, including the first gene therapy for hemophilia A. 24 June 2022
Merck & Co today announced that the European Commission (EC) has approved Keytruda (pembrolizumab) Merck’s mega-blockbuster anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection. 24 June 2022
Shares of German biotech BioNTech closed up almost 7% at $132.29 yesterday, after the company – which burst on the scene with its hugely successful COVID-19 vaccine Comirnaty – announced a important development for its wider portfolio. 24 June 2022
The European Medicines Agency (EMA) has recommended granting a marketing authorization for COVID-19 Vaccine (inactivated, adjuvanted) Valneva, developed by developed by French company Valneva, for use in the primary vaccination of people from 18 to 50 years of age. 23 June 2022
Swiss pharma giant Novartis today announced that the European Commission (EC) approved Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. 23 June 2022
After repeated failures to register its Duchenne muscular dystrophy (DMD) drug in the USA, new data suggest PTC Therapeutics might be about ready to try again. 22 June 2022
The European Medicines Agency (EMA) has validated the type II variation application for extension of the indication for Breyanzi (lisocabtagene maraleucel) to treat adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who are refractory or have relapsed within 12 months of initial therapy and are candidates for hematopoietic stem cell transplant (HSCT). 21 June 2022
Stelis Biopharma, a contract development and manufacturing organization (CDMO) and the biologics arm of India's Strides Pharma Science, has received the European Union Goods Manufacturing Practices (EU-GMP) compliance certificate from the National Institute of Pharmacy and Nutrition, Hungary, for two of its manufacturing facilities. 21 June 2022
At its June 16, 2022, meeting in Amsterdam, the European Medicines Agency's (EMA) management board, among other items, heard an update about the implementation of the new EU regulation that reinforces EMA’s role in crisis preparedness and management for medicinal products and medical devices. 20 June 2022
As part of its advice on safety-related aspects to European Medicines Agency committees stemming from its June 7-10 meetings, the Pharmacovigilance Risk Assessment Committee (PRAC) discussed direct healthcare professional communications (DHPCs) containing important information for Neofordex (dexamethasone) and Xalkori (crizotinib). 11 June 2022
The European Commission has granted conditional marketing authorization for the CD20xCD3 T-cell engaging bispecific antibody Lunsumio (mosunetuzumab), developed by Swiss pharma giant Roche. 8 June 2022
Roche has won approval from the European Commission (EC) for the use of Polivy (polatuzumab vedotin) in combination with MabThera (rituximab) plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) for adults with untreated diffuse large B-cell lymphoma (DLBCL). 26 May 2022
Following a European Medicines Agency recommendation in March, the European Commission has now granted formal approval for Carvykti (ciltacabtagene autoleucel, or cilta-cel), from Johnson & Johnson’s subsidiary Janssen. 26 May 2022
Merck & Co’s blockbuster drug Keytruda (pembrolizumab) has been approved by the European Commission alongside chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for adults with locally advanced or early-stage triple-negative breast cancer (TNBC) at high risk of recurrence. 25 May 2022