Pfizer announced it has entered into an exclusive global collaboration and license agreement with Chongqing Yao ...

Scientific advice by EMA. At different stages of your development process, you can go for scientific advice with the EMA. While this service is not free, the associated fees can vary, typically ...

Carvykti’s emerging Phase III data shows that a single early-line infusion can deliver durable, treatment-free remissions ...

In today’s Pharmaceutical Executive Daily, the FDA greenlights an expanded use of Breyanzi, Eli Lilly reports Jaypirca met ...

For Phase III trial planning, two suggestions may have merit. Include sizeable subpopulations that payers cannot easily ...

Jaypirca is approved for the treatment of adults with relapsed or refractory CLL/SLL who were previously treated with a ...

When borders become bottlenecks, leadership—not luck—keeps medicines flowing to the patients that need them. The companies that adapt these new practices will find new opportunities in the changed ...

PE: How are global regulatory agencies adjusting their policies for biosimilars? Woollett: The clear leaders in the space of biosimilar development have been the European agency, the UK, and US FDA.

Gillian Woollett, VP and head of regulatory strategy at Samsung Bioepis, discusses how the current regulatory climate is the result of years of work.

FDA’s approval of Bristol Myers Squibb’s Breyanzi as the first CAR T therapy for relapsed or refractory marginal zone lymphoma underscores the therapy’s expanding leadership in B-cell malignancies, ...

In today’s Pharmaceutical Executive Daily, the FDA appoints Tracy Beth Høeg as acting CDER director, health systems explore ...