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…
FDA unveils new pathway for rare disease treatments
The Trump administration on Monday released detailed guidance for approving the first bespoke medicines crafted to treat patients’ individual…
Key study of Grail’s cancer detection test fails in setback for company
Angus Chen covers all issues broadly related to cancer including drugs, policy, science, and equity. He joined STAT…
FDA reverses course, agrees to review Moderna’s flu vaccine
WASHINGTON — The Food and Drug Administration reversed course and told Moderna it would review its application for…
What the FDA’s Moderna rejection means for every vaccine maker
The Food and Drug Administration’s refusal to review Moderna’s flu vaccine this month has renewed fears that Trump…
Moderna’s president weighs in on FDA’s decision not to review its flu vaccine
Food and Drug Administration officials told Moderna in August that they would review its application for a new…
Prasad takes a familiar, conservative approach to drug approvals
Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall…
Sanofi replaces Paul Hudson as CEO with Belén Garijo
Andrew Joseph covers health, medicine, and the biopharma industry in Europe. You can reach Andrew on Signal at…
Prasad overruled FDA staff to reject Moderna flu vaccine application
WASHINGTON — Top Food and Drug Administration official Vinay Prasad overruled the agency’s reviewers when he refused to accept…