News

Stealth Bio to cut jobs after FDA rejects therapy for rare disorder
By Sriparna Roy (Reuters) -Privately held Stealth BioTherapeutics said on Thursday the U.S. Food and Drug Administration had ...
US FDA approves Alcon's new dry-eye drug
Spun off from Novartis in 2019, Alcon is betting on new product launches to accelerate sales growth in the second half of ...
JD Supra35m
Food for Thought Implications of FDAs New Chemical Review Program
The US Food and Drug Administration recently announced a major initiative to strengthen oversight of food additives and other ...
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A rare disease drug is rejected, even as the FDA talks about new approval pathway
Instead of approving Stealth BioTherapeutics' drug for Barth syndrome, the FDA withheld its endorsement, but decided it may ...
US FDA asks Stealth BioTherapeutics to resubmit application for rare genetic condition therapy
The U.S. Food and Drug Administration has asked for a resubmission of Stealth BioTherapeutics' marketing application for its ...
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FDA Slams Pfizer for Talzenna Biomarker-Free Push
The FDA approved the poly ADP ribose polymerase (PARP) inhibitor in June 2023 in combination with enzalutamide for men with ...
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FDA Approves Ustekinumab Biosimilar Starjemza
The Food and Drug Administration (FDA) has approved Starjemza ® (ustekinumab-hmny), a biosimilar to Stelara ® (ustekinumab), for the treatment of various chronic inflammatory diseases. Starjemza, ...
Daily Mail3d
FDA - Latest News and updates on the US Food and Drug Administration
The first time I injected myself with one of the new GLP-1 weight-loss drugs in spring 2023 ... Then my relationship to food began to change. Soon after I was having dinner with my family ...
Do you take one of these common allergy medicines? You may experience a rare side effect, FDA warns
“Reported cases were rare but sometimes serious, with patients experiencing widespread, severe itching that required medical ...
Tomato Recall Update as FDA Issues Highest Warning Level
The Centers for Disease Control and Prevention has estimated that salmonella causes about 420 deaths annually in the U.S.
Cucumbers top FDA recall list for May 2025 due to salmonella risk. See full list
More than 10 food items were recalled for salmonella on the FDA's recalls, market withdrawals and safety alerts list for May 2025. See full list.
Trump administration proposes cutting FDA budget by 5.5%
The Trump administration is proposing a $6.8 billion budget request for the U.S. Food and Drug Administration for the 2026 ...