Articles by tag: ema-approval

CRISPR gene therapy for children with anemia: EMA approval 2026

EMA approved CASGEVY for children 5-11 years with sickle cell anemia. 100% efficacy, price 1.8 million EUR. Risks and benefits — in the analysis. Learn more.

Digital stethoscope for diagnosing heart failure by voice | New EMA technology

Analysis of remote monitoring technology for heart failure by voice: truth about EMA approval, comparison of methods, forecasts. Learn more.

EMA approval of first-line treatment for aggressive colon cancer

EMA recommended encorafenib + cetuximab + FOLFOX for first-line BRAF V600E-mutant mCRC. 47% reduction in risk of progression. Read analysis and BREAKWATER study data.

EMA approved the first therapy for PROS: analysis of Vijoice

Despite the failure of the confirmatory study, EMA approved alpelisib for severe PROS syndrome. We analyze the mechanism, risks, and prospects of Vijoice.

EMA approved Jascayd: the first drug for the treatment of pulmonary fibrosis

EMA has approved for the first time Jascayd (nerandomilast) for the treatment of idiopathic and progressive pulmonary fibrosis. Advantage of 68.8 mL, mortality reduction of 43%. Learn about the breakthrough in pulmonology.

Oral GLP-1 tablet for weight loss: EMA analysis

EMA decision analysis on oral semaglutide (Wegovy Pill). OASIS 4 data, investments in Ireland and competition with Lilly. Read forecasts and hidden risks.

EMA accepted the application for Dovato for children with HIV

EMA validated the application for the use of Dovato in children from 3 months with HIV. Learn how this will change pediatric therapy and strengthen ViiV's position. Read the detailed analysis.

Pediatric Dovato: EMA Approves Application for HIV Therapy

EMA validated the application for pediatric Dovato (dolutegravir/lamivudine) for children from 2 years old. Learn how two-drug therapy is changing HIV treatment standards.

SaRNA vaccine for cats: EMA decision as a breakthrough for medicine

EMA has approved the first RNA vaccine for animals. We analyze why this decision opens a new wave in human medicine and changes the market. Get insights.

EMA approved SMA gene therapy Itvisma and a drug for MS

European regulator recommended Itvisma for adults with SMA and Cenrifki for secondary progressive sclerosis. Learn how a one-time injection and a pill fill gaps in neurodegeneration treatment.