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…
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…
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…
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…
FDA refuses to review Moderna’s flu vaccine application
Helen Branswell covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Follow her…
Selective depletion of tumor-associated SAMHD1 enhances chemotherapeutic efficacy and antitumor immune responses
Study approval All experimental animal procedures were performed in compliance with the Chinese. The study was conducted in…
Embattled FDA official defends vaccine plan in closed-door remarks
Damian Garde is a reporter at large, live and feature journalism, covering the global drug industry and contributing…
Tracy Beth Høeg will lead FDA Center for Drug Evaluation and Research
WASHINGTON — Tracy Beth Høeg, a top lieutenant to Food and Drug Administration Commissioner Marty Makary, will be…
Top FDA regulator accused of using office to settle personal vendetta
Andrew Joseph covers health, medicine, and the biopharma industry in Europe. You can reach Andrew on Signal at…
George Tidmarsh, Uniqure, Pfizer, Metsera: Readout Newsletter
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FDA approves Blenrep, a GSK blood cancer drug with unusual history
Andrew Joseph covers health, medicine, and the biopharma industry in Europe. You can reach Andrew on Signal at…
Summit Therapeutics hits possible snag on lung cancer drug seen as blockbuster
Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall…