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2 days ago · This study examined 81 projects and found that the median development time from first-in-human study initiation to obtaining marketing authorisation was 7.3 years. However, there was considerable variability, with the fastest project taking only 8 months and the slowest extending to 223 months. The analysis revealed that vaccines and drugs ...
5 days ago · AstraZeneca’s Marketing Authorisation Application (MAA) for sipavibart has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for the pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised patients.
3 days ago · “The EMA’s approval of Dupixent has addressed a current gap in the market for COPD – the absence of biologics. The key opinion leaders (KOLs) interviewed by GlobalData have shared optimistic views on Dupixent, noting that its novel pathway presents anti-mucous effects, which is an additive value, supplementing its anti-eosinophil effects.
2 days ago · Organisation chart of the European Medicines Agency. Media enquiries. Tel. +31 (0)88 781 8427. E-mail: press@ema.europa.eu. All other enquiries. please submit your request via the online form. Follow us on X @EMA_News.
4 days ago · Large Cap Fiat-Backed Stablecoins Depegged Over 600 Times in 2023: Moody’s Analytics. Circle became the first global stablecoin issuer to secure an Electronic Money Institution (EMI) license, a ...
3 days ago · The European Medicines Agency (EMA) has approved Sanofi ‘s Dupixent (dupilumab) as the first targeted therapy for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils. This authorisation is specifically for patients receiving a combination of inhaled corticosteroid (ICS), long-acting ...
5 days ago · As a result, EMA has established an Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to play a central role in coordinating, preventing and mitigating medicine shortages in the EU.
