Topic
28 recent stories.
Policy / European Union
The European Medicines Agency's PRIME initiative aims to expedite the development and assessment of innovative treatments, focusing on medications addressing high unmet medical needs.
08 May 2026
Policy / European Union
The European Medicines Agency has issued a positive opinion on the Dengue Tetravalent Vaccine (Live, Attenuated) created by Takeda for use outside the EU, highlighting its effectiveness in preventing severe dengue disease in children and adolescents.
08 May 2026
Policy / European Union
The European Medicines Agency has initiated a safety review of certain combination pain relief medications, including those containing buclizine and codeine. The decision reflects ongoing efforts to ensure the safety of pharmaceutical products in the EU.
08 May 2026
Policy / European Union
The European Medicines Agency has authorized Tenofovir Disoproxil Viatris, a generic drug to treat HIV and Hepatitis B, underlining its safety and effectiveness compared to its reference medicine, Viread.
08 May 2026
Policy / European Union
Strimvelis, an innovative gene therapy for treating severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID), has been approved for use in the EU, offering hope to patients without suitable bone marrow donors.
08 May 2026
Policy / European Union
Talmanco, a new generic medicine for pulmonary arterial hypertension (PAH), has been granted marketing authorization by the European Commission, providing an alternative treatment option for patients.
08 May 2026
Policy / European Union
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency reviewed crucial safety policies during its May meeting, highlighting no new safety referrals or urgent actions.
08 May 2026
Policy / European Union
Pregabalin Viatris, a generic form of the widely used medication Lyrica, has been formally recognised by the European Medicines Agency for its efficacy in treating neuropathic pain and anxiety disorders in adults.
08 May 2026
Society / European Union
The European Medicines Agency has announced the discontinuation of a pediatric investigation plan for a medication, AZD7594, due to insufficient data to support its development.
08 May 2026
Society / European Union
The EMA has announced the discontinuation of a paediatric development plan for a house dust mite allergen extract, raising concerns regarding treatment accessibility for young patients.
08 May 2026
Society / European Union
The European Medicines Agency has confirmed the discontinuation of paediatric development for allopregnanolone, highlighting ongoing challenges in paediatric medication advancements.
08 May 2026
Policy / European Union
Dupixent (dupilumab) has been officially recognized for its efficacy in treating various chronic inflammatory diseases, marking a significant advance in therapeutic options since its authorization in 2017.
08 May 2026
Policy / European Union
Mysildecard, a generic form of sildenafil, has received EU approval for treating pulmonary arterial hypertension in both adults and children. The treatment aims to improve exercise capacity by dilating blood vessels in the lungs.
07 May 2026
Society / European Union
The European Commission has granted indefinite marketing authorization for Febuxostat Viatris, a generic medication indicated for treating high uric acid levels in gout sufferers and cancer patients undergoing chemotherapy. Approved since June 2017, the drug is recognized for its efficacy and safety profile, presenting a viable option within the region.
07 May 2026
Policy / European Union
The European Medicines Agency has authorized Darunavir Viatris, a generic antiviral medication for treating HIV-1 infection, emphasizing its bioequivalence to the reference drug Prezista.
07 May 2026
Society / European Union
The European Commission has officially withdrawn the marketing authorization for Rapilysin, a treatment indicated for myocardial infarction. The decision was initiated by the product's holder, Actavis Group, due to commercial reasons.
07 May 2026
Policy / European Union
Loqtorzi, a monoclonal antibody for cancer treatment, receives EU marketing authorization due to its promising efficacy in extending survival for patients with advanced nasopharyngeal and esophageal cancers, despite known side effects.
07 May 2026
Society / European Union
The European Medicines Agency has granted marketing authorisation for Atazanavir Viatris, a new generic HIV treatment that promises to be an effective option for patients aged 6 and over, particularly alongside low-dose ritonavir.
07 May 2026
Society / European Union
The European Medicines Agency has outlined new strain recommendations for the upcoming flu season, eliminating the need for the B/Yamagata strain as it is no longer circulating.
07 May 2026
Society / European Union
The European Commission has withdrawn the marketing authorisation for Truvelog Mix 30 at the request of Sanofi Winthrop Industrie. This insulin aspart product was approved less than two years ago for diabetes treatment.
07 May 2026
Policy / European Union
The European Medicines Agency (EMA) has reaffirmed the approval of CellCept, a vital immunosuppressant used to prevent organ rejection in transplant patients, seen as more effective than alternatives.
07 May 2026
Policy / European Union
Uplizna (inebilizumab), effective for reducing NMOSD and IgG4-related disease symptoms, has gained conditional approval in the EU. Key usage protocols and safety guidelines are outlined for healthcare providers.
07 May 2026
Society / European Union
The European Medicines Agency has confirmed the ongoing authorization of Olumiant, a drug prescribed for moderate to severe rheumatoid arthritis, atopic dermatitis, alopecia areata, and juvenile idiopathic arthritis. Originally approved in 2017, this drug has shown significant efficacy and safety in clinical trials.
07 May 2026
Policy / European Union
The European Medicines Agency has authorized Kerendia (finerenone), a new treatment for adults with chronic kidney disease linked to type 2 diabetes, citing its benefits in slowing kidney function decline and reducing cardiovascular risks.
07 May 2026
Policy / European Union
Dovprela, an antibiotic for multidrug-resistant tuberculosis, has received standard authorisation from the European Medicines Agency, moving beyond its initial conditional approval.
07 May 2026
Policy / European Union
Oncaspar, a cancer drug for treating acute lymphoblastic leukaemia in both adults and children, has been authorized by the European Medicines Agency, offering new hope for patients including those allergic to previous treatments.
07 May 2026
Policy / European Union
The European Medicines Agency (EMA) has granted authorisation for Usgena, a new biosimilar medicine based on ustekinumab, used to treat plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
07 May 2026
Society / European Union
The European Medicines Agency has established a new advisory group aimed at tackling vaccine hesitancy and improving public trust in vaccination.
07 May 2026