U.S. FDA

VanNaarden
Biotech

Lilly oncology head weighs in on FDA cancer drug policies

Lilly’s oncology chief, Jake Van Naarden, suggested that the FDA's policies on clinical trial crossover and high U.S. enrollment are not compatible.
Angus Liu Oct 21, 2025 11:53am
Graphic of a fork in the road with arrows pointing in either direction
Favicon Fierce Pharma

Prasad exit signals more permissive FDA for cell and gene field

Jul 31, 2025 9:10am
FDA
Favicon Fierce Pharma

Vinay Prasad departs FDA amid controversy over gene therapy

Jul 30, 2025 9:33am
sarepta building
Favicon Fierce Pharma

FDA backtracks on Sarepta's gene therapy Elevidys in DMD

Jul 28, 2025 6:02pm
FDA
Favicon Fierce Pharma

FDA eyeing study requirements to confirm Elevidys safety: report

Jul 24, 2025 3:12pm
Sarepta Sarepta Therapeutics
Favicon Fierce Pharma

Sarepta will continue shipping Elevidys despite FDA misgivings

Jul 21, 2025 10:42am