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Biotechnology
The European Commission (EC) has approved US pharma giant Pfizer’s Talzenna (talazoparib) in combination with Xtandi (enzalutamide), for the treatment of adult patients with metastatic castration-resistant 9 January 2024
Biotechnology
Belgium’s UCB has won European Commission (EC) approval for Rystiggo (rozanolixizumab) as an add-on to standard therapy for generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. 8 January 2024
Pharmaceutical
US drugmaker Cidara Therapeutics’ shares advanced 12.5% to $0.83 on Friday, after it announced that Rezzayo (rezafungin acetate) has been approved in the European Union (EU) for the treatment of invasive candidiasis in adults. 23 December 2023
Biotechnology
Last month, the European Commission (EC) approved Ebglyss (lebrikizumab) for the treatment of adult and adolescent patients with moderate-to-severe atopic dermatitis (AD), who are candidates for systemic therapy. 21 December 2023
Generics
US biotech major Biogen today announced that the European Commission has revoked the centralized marketing authorizations for generic versions of the company’s multiple sclerosis therapy, Tecfidera (dimethyl fumarate). 19 December 2023
Biotechnology
The European Commission has extended the approval of Evkeeza (evinacumab) as an adjunct to diet and other lipid-lowering therapies to treat children aged five to 11 years with homozygous familial hypercholesterolemia (HoFH). 19 December 2023
Biotechnology
The European Commission (EC) has approved two new indications for Keytruda (pembrolizumab). 18 December 2023
Pharmaceutical
Swiss specialty pharma Santhera Pharmaceuticals has announced that Agamree (vamorolone) has been approved in the European Union (EU) to treat Duchenne muscular dystrophy (DMD) in patients four years of age and older, independent of the underlying mutation and ambulatory status. 18 December 2023
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended a number of new and generic medicines for approval at its December 2023 meeting. 15 December 2023
Pharmaceutical
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the first version of the Union list of critical medicines. 12 December 2023
Biotechnology
The US Food and Drug Administration (FDA) has accepted Pfizer’s Biologics License Application (BLA) for its anti-tissue factor pathway inhibitor (anti-TFPI) candidate marstacimab for individuals living with hemophilia A or hemophilia B without inhibitors to Factor VIII (FVIII) or Factor IX (FIX). 12 December 2023
Biotechnology
The European Commission (EC) has granted marketing authorization of a new indication Jemperli (dostarlimab), from UK pharma major GSK. 11 December 2023
Pharmaceutical
The European Commission (EC) has authorized Japanese drugmaker Astellas Pharma’s Veoza (fezolinetant) 45mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. 11 December 2023
Biotechnology
Adding to its US regulatory clearance in August, the European Commission (EC) has now also granted conditional marketing authorization for Elrexfio (elranatamab), from US pharma giant Pfizer. 8 December 2023
Pharmaceutical
The European Commission (EC) has granted a marketing authorization for Zilbrysq (zilucoplan) as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. 4 December 2023
Pharmaceutical
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended new measures for medicines containing pseudoephedrine. 1 December 2023
Pharmaceutical
The European Medicines Agency (EMA) has validated Vertex Pharmaceuticals Type II variation application to the Marketing Authorization for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor. 24 November 2023
Biotechnology
The European Commission has granted approval for the label expansion of Kaftrio (ivacaftor/tezacaftor/elexacaftor; marketed in the USA as Trikaftra) in a combination regimen with ivacaftor for the treatment of children with cystic fibrosis (CF) ages two through five years old who have at least one F508del mutation in the cystic fibrosis (CF) transmembrane conductance regulator (CFTR) gene, US biopharma Vertex Pharmaceuticals announced today. 23 November 2023
Biotechnology
Janssen says it has submitted a type II extension of indication application to the European Medicines Agency (EMA) seeking approval of Rybrevant (amivantamab). 23 November 2023
Pharmaceutical
Japanese ophthalmology firm Santen Pharmaceutical has received marketing authorization from the European Commission for Catiolanze (cationic emulsion of latanoprost 50μg/mL, STN1013001). 20 November 2023
Pharmaceutical
AstraZeneca has received European approval for a fixed-duration regimen of Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, for adults newly diagnosed with chronic lymphocytic leukemia (CLL). 6 June 2025
Pharmaceutical
The European Commission has granted market authorization for Japanese ophthalmic drugmaker Santen Pharmaceutical’s Ryjunea, a low-dose atropine eye drop (0.1mg/ml), that slows the progression of pediatric myopia, marking a significant advance in pediatric eye care. 5 June 2025
Pharmaceutical
The European Commission (EC) has approved a label extension for Evrysdi (risdiplam) to include a new, room-temperature stable tablet for people living with spinal muscular atrophy (SMA), Swiss pharma giant Roche revealed today 4 June 2025
Biotechnology
The European Commission (EC) has approved Adcetris (brentuximab vedotin) in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) – a chemotherapy regimen – in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma. 4 June 2025
Pharmaceutical
Shares in MaaT Pharma, a French microbiome company in oncology, closed 25% higher Tuesday. 3 June 2025
Biotechnology
US pharma major Bristol Myers Squibb has announced that the European Commission (EC) has approved a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). 2 June 2025
Pharmaceutical
Industry stakeholders have urged the European Medicines Agency to sharpen its guidance on decentralized clinical trials, calling for more practical detail in a key international framework on good clinical practice. 30 May 2025
Biotechnology
The European Commission (EC) has approved a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). 29 May 2025
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended six novel medicines for approval at its May 2025 meeting. Final approvals from the European Commission are now expected in the third quarter of this year. 23 May 2025
Pharmaceutical
The European Medicines Agency’s (EMA) Emergency Task Force (EFT) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant LP.8.1 for the 2025/2026 vaccination campaign. 19 May 2025
Pharmaceutical
Vaccines Europe’s response to the Call for Evidence on the European Centre for Disease Prevention and Control evaluation Vaccines Europe (VE) welcomes the evaluation of the European Centre for Disease Prevention and Control (ECDC). 19 May 2025
Biotechnology
The European Commission (EC) has approved a Marketing Authorization (MA) for Tremfya (guselkumab) to treat adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. 8 May 2025
Pharmaceutical
Following a European Union-wide review of available data on finasteride and dutasteride medicines, the European Medicines Agency’s (EMA) safety committee (PRAC) has confirmed suicidal ideation (suicidal thoughts) as a side effect of finasteride 1mg and 5mg tablets but concluded that the benefits of finasteride and dutasteride medicines continue to outweigh their risks for all approved uses. 8 May 2025
Biotechnology
Sino-American biotech BeiGene today announced that the European Commission has approved Tevimbra (tislelizumab), in combination with etoposide and platinum chemotherapy, as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC). 8 May 2025
Pharmaceutical
UK pharma major AstraZeneca today revealed that its Calquence (acalabrutinib) in combination with bendamustine and rituximab has been approved in the European Union (EU) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant. 6 May 2025
Pharmaceutical
The European Commission has approved the conversion of the conditional marketing approval (CMA) into a standard marketing authorization (MA) for Filspari (sparsentan). 29 April 2025
Biotechnology
Regeneron Pharmaceuticals today announced that the European Commission (EC) has granted conditional marketing approval of Lynozyfic (linvoseltamab) to treat adults with relapsed and refractory (R/R) multiple myeloma. 28 April 2025
Pharmaceutical
The European Medicines Agency’s (EMA)) human medicines committee (CHMP) has recommended seven novel medicines for approval at its April 2025 meeting. A final decision from the European Commission is usually issued in about two months. 26 April 2025
Biotechnology
The European Commission (EC) has approved a marketing authorization (MA) for Tremfya (guselkumab) to treat adults with moderately to severely active ulcerative colitis (UC) who had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. 25 April 2025
Pharmaceutical
Denmark-based allergy immunotherapy specialist ALK Abello today announced that its Itulazax (tree pollen sublingual allergy immunotherapy tablet) has been approved by the European regulator for treatment of young children and adolescents aged five to 17. 23 April 2025
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