GSK plc GSK recently announced that EMA has accepted the regulatory filing seeking approval for its IL-5 inhibitor ...

CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars:  On January 30, 2025, the European Medicines Agency (EMA) Committee ...

In looking across the past four years of regulatory decisions, we noticed that some of the analyses involving the European Medicines Agency (EMA)'s cycle time used an inappropriate endpoint, which ...

Telethon Foundation is seeking approval for a gene therapy to treat the rare disease Wiskott-Aldrich syndrome.

8 It’s encouraging to see this as one of the goals in the EMA’s 2025 Regulatory Sciences Strategy. 8 We really must do more to reduce access delays and advance health equity, and put better ...

GSK (GSK) announced that the European Medicines Agency, EMA, has accepted for review the regulatory application of a prefilled syringe ...

In the United States, the biomedical industry encounters numerous regulatory challenges in conducting nonclinical and ...

Ibezapolstat has previously been granted FDA QIDP and Fast-Track Designation from FDA and Acurx has received SME (Small and Medium-sized Enterprise) designation by the EMA to benefit from fee ...

uncertainties inherent in the regulatory approval process could impact the timing, progress, and outcome of the EMA’s review; potential delays or difficulties in commercializing mavorixafor in Europe ...