Trump set to fire FDA Commissioner Marty Makary after stormy tenure
President Trump has reportedly signed off on a plan to dismiss Food and Drug Administration Commissioner Marty Makary.…
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…
Revolution Medicines touts success in pancreatic cancer treatment
Metastatic pancreatic cancer patients who received a targeted pill from Revolution Medicines lived nearly twice as long as…
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…
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…