Daily Archives: September 30, 2010

Insight into FDA’s Thinking on a Biosimilar Regulatory Pathway?

Today Teva Pharmaceuticals announced the receipt of a Complete Response Letter from the FDA for their Biological Licence Application (BLA) for Neutroval.  Neutroval is a treatment to reduce the duration of severe neutropenia and the incidence of febrile neutropenia in … Continue reading

Posted in Biologics | 2 Comments