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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…
- Rapport Therapeutics' epilepsy drug RAP-219 meets primary endpoint in bipolar mania Phase II trialRapport Therapeutics reported that its experimental pill RAP-219, originally developed for epilepsy, was tested in a mid‑stage study of adults with bipolar mania. The trial enrolled roughly 250 par…