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 ...

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

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

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 ...

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.

Eli Lilly reduced Zepbound vial prices for self-paying patients via LillyDirect, aiming to lower obesity treatment costs and ...

The agency’s decision is based on claims that the Covid vaccine was linked to the deaths of 10 children.

Along with the deployment and integration the new agentic AI tool, FDA is also launching an agentic AI challenge for its ...

Dr. Pazdur’s decision comes just weeks after being appointed as the head of CDER earlier in November this year.His ...

New data shows that China and the US dominate breast cancer clinical trial expertise while lower-income countries remain ...