Articles by tag: ema

Orphan status of combination for lung cancer treatment: new EMA approach

European Commission granted orphan status to Zepzelca combination with atezolizumab for lung cancer. Learn how EMA reform changes rules for SCLC and who benefits from this decision. Detailed analysis.

Gene therapy for deafness otarmeni EMA: accelerated review 2026

EMA accepted the application for gene therapy otarmeni for the treatment of hereditary deafness OTOF. Market analysis, forecasts, price and implications for the industry. Read.

Oral Ebola inhibitor: post-exposure prophylaxis

We analyze what EMA actually recommended regarding the first oral drug against Ebola. Key facts, logistics, and forecasts. Read.

EMA recommended the first oral GLP-1 drug for weight loss | Wegovy

EMA issued a positive opinion on the first oral GLP-1 Wegovy for weight loss. Analysis of efficacy, price, side effects and market forecast. Read details.

EMA approved the first oral GLP-1 drug Wegovy for weight control

EMA recommended the first GLP-1 tablet for weight loss — Wegovy (semaglutide) 25 mg. Efficacy up to 16.6% weight loss. Market analysis, winners and losers. Learn more.

New Boey neurotoxin for glabellar lines: EMA recommendation

European regulator approved Boey (trenibotulinumtoxin E) for correction of glabellar lines. Learn about onset of effect in 8 hours, duration of 2-3 weeks, and market implications.

EMA launches pilot: breakthrough medical devices

EMA tests accelerated pathway for innovative class III and IIb devices. Free consultations for cardiovascular and pediatric technologies. Apply by May 22.