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- Pharma companies push FDA for risk-based flexibility in container-closure testing guidanceMajor pharma firms have written to the FDA urging a shift in its current guidance on testing container-closure systems for drug and biologic products. They argue that a risk-based, flexible approa…
- FDA approves Hibsago, first antisense therapy for chronic hepatitis BThe U.S. Food and Drug Administration has approved Hibsago (bepirovirsen) injection to be used alongside existing antiviral therapy for chronic hepatitis B virus infection in certain adults without…