News

Healio1d
FDA approves natural color additive gardenia blue, asks for quicker phase-out of Red No. 3
The FDA has approved the natural color additive gardenia (genipin) blue for use in various foods and drinks at “levels ...
PharmExec7d
AI’s Realistic Capabilities in FDA’s Approval Process
One of the concerns people have when they hear FDA is using AI in the drug approval process is that many people don't have a ...
PharmExec1d
Is AI Replacing Laid Off FDA Workers?
Marcel Botha discusses whether AI can truly be used to replace laid off human workers at FDA.
Opinion
FDA should judge drugs on what they do in real life, not just in companies’ clinical trials
Under the new leadership of Marty Makary, the FDA should focus more attention on the critical role of real-world clinical data — such as from health insurance databases — in the ongoing assessment of ...
FDA Commissioner: 100 Days of Change—Modernizing the FDA for a Healthier America | Opinion
The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and ...
Healio4d
FDA approves Moderna COVID-19 vaccine for some children
The FDA this week fully approved Moderna’s COVID-19 vaccine for children aged 6 months to 11 years but limited the approval ...
US FDA publishes 200 complete response letters from archive in transparency drive
The U.S. Food and Drug Administration on Thursday publicly shared over 200 archived so-called complete response letters ...
Fierce Pharma5d
‘Weak’ evidence and an ‘unpleasant’ odor: FDA sheds light on drug refusal process
When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view | ...
CURE13d
Zegfrovy FDA Approved for EGFR Exon 20 Non-Small Cell Lung Cancer
The FDA approved Zegfrovy for advanced non-small cell lung cancer with EGFR exon 20 mutations after chemotherapy.