The study found that just 20% of trials submitted to both the FDA and European Medicines Agency had matching evidence.

DelveInsight's "BAVENCIO Market Size, Forecast, and Market Insight Report" highlights the details around BAVENCIO, a human ...

Post-authorisation safety studies (PASS) are often seen simply as a regulatory necessity, a checkbox that ensures ongoing ...

STOBOCLO ® (denosumab-bmwo) and OSENVELT ® (denosumab-bmwo) are approved by FDA for all indications of reference products ...

Namodenoson is currently being evaluated in Liveration TM, a pivotal Phase III study for advanced liver cancer that has been ...

Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, have been approved by the FDA, EMA, and MHRA; FYB202 is ...

This represents a >350-fold variation in the incidence among the 100 populations worldwide (Table 1). One-third of the populations (33 of 100) had an intermediate incidence of type 1 diabetes.

The positive CHMP opinion is supported by data from the pivotal LINKER-MM1 trial, which evaluated linvoseltamab in adults with R/R MM. Earlier this month, the FDA accepted for review the Biologics ...

Dublin, Feb. 27, 2025 (GLOBE NEWSWIRE) -- The "3hr Virtual Seminar - Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA/EMA, USP and ICH" training has been ...

Phase 3 ECLIPSE registrational clinical program in chronic hepatitis delta on track to begin in the first half of 2025 - Tobevibart and elebsiran in chronic hepatitis delta received U.S. FDA ...