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Latest From Kite Pharma
The European Medicines Agency has recommended new uses for six approved products, including the CAR T-cell therapy Tecartus.
If Roche gets the nod from the European Medicines Agency for mosunetuzumab this week, it could become the first company to market a CD20xCD3 bispecific antibody for follicular lymphoma.
Proactive US FDA Propelled Review Of Genentech’s Actemra In Systemic Sclerosis Amid Evolving Regulatory Landscape
Pink Sheet’s Drug Review Profile series looks at the unusual history of a systemic sclerosis interstitial lung disease indication for Genentech’s Actemra that was revived at the FDA’s behest and vetted by CDER’s high-level CDER policy council.
Draft from US FDA advises sponsors on how to draw from platform knowledge, while anticipating issues associated with emerging centralized and distributed manufacturing approaches for autologous and allogeneic products and their viral vectors.