Regenxbio says Duchenne gene therapy succeeded in clinical trial
Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall…
Intellia Therapeutics moves HAE treatment closer to approval
Intellia Therapeutics said Monday that a single dose of its gene editing treatment dramatically reduced swelling attacks in…
Erasca touts strong early results in pancreatic and lung cancer therapy trial
Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall…
Eli Lilly’s $3.25B acquisition of Kelonia Therapeutics caps startup’s tortuous ride
Eli Lilly is spending $3.25 billion to acquire Kelonia Therapeutics, a small biotech company developing cell therapies for…
Replimune skin cancer drug that became FDA flashpoint is rejected again
The Food and Drug Administration on Friday rejected — again — an experimental treatment for advanced skin cancer…
Trump administration readies tariffs for imported drugs
WASHINGTON — The Trump administration has prepared an order that would impose a 100% tariff on imports of…
Baby KJ researchers face FDA hurdle on scaling custom treatments
The scientists behind treating Baby KJ say they’ve hit a stumbling block in their efforts to create more…
J&J wins approval for first-of-its-kind psoriasis pill
Damian Garde is a reporter at large, live and feature journalism, covering the global drug industry and contributing…
BioNTech founders to leave, form new mRNA-focused company
Andrew Joseph covers health, medicine, and the biopharma industry in Europe. You can reach Andrew on Signal at…
Vertex says drug reduced marker of kidney disease in late-stage trial
Vertex said Monday that a drug it secured as part of a $4.9 billion acquisition successfully reduced by…
5 lessons from Vinay Prasad’s turbulent tenure at the FDA
Food and Drug Administration official Vinay Prasad self-destructed last week. The FDA announced Friday evening that he would…