FDA limits toxic lead in baby food, but Illinois rep says more should be done
The Food and Drug Administration put guidelines in place to curb the amount of lead in baby food, but some like one Illinois ...
Rigel Announces R289 Granted Orphan Drug Designation by the FDA for MDS
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and ...
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Leaving FDA, Califf is unapologetic — and warns of staff departures
In an interview, outgoing FDA commissioner Robert Califf was wary of the Trump administration but unapologetic about ...
PureTech Drug Gets FDA Fast-Track Designation for Leukemia
The biotherapeutics company said the treatment, LYT-200, is being evaluated in two ongoing clinical trials. It was previously granted orphan drug designation for the treatment of acute myeloid ...
Johnson & Johnson Gets FDA Priority Review of Nipocalimab in Generalized Myasthenia Gravis
Johnson & Johnson has won Food and Drug Administration priority review for its application seeking approval of nipocalimab in certain patients with generalized myasthenia gravis.
Nipocalimab granted U.S. FDA Priority Review for the treatment of generalized myasthenia gravis
Johnson & Johnson (NYSE: JNJ) today announced the nipocalimab Biologics License Application (BLA) received Priority Review designation from the U.S Food and Drug Administration (FDA) for the treatment ...
Lupin receives US FDA tentative approval for Ivacaftor Oral Granules
These granules, available in 25 mg, 50 mg, and 75 mg per unit dose packets, are a generic equivalent of Kalydeco Oral ...
Advocates urging FDA to ban shock device used in Mass. school ASAP
There's an urgent push underway to get the U.S. Food and Drug Administration to finally ban the devices that administer ...
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FDA pushes makers of AI devices to disclose more details on testing, performance
The FDA wants the developers of medical devices that rely on AI to disclose more detail about how their devices were ...
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Balancing Safety and Accessibility: FDA Broadens Approval Pathway for Nonprescription Drugs by Finalizing the ‘ACNU’ Rule
The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug ...
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FDA recalls in 2025: Products include broccoli, chocolate bars and more
Express US takes a look at the products which have been recalled by the Food and Drug Administration since the start of ...
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FDA adds warning to RSV shots from GSK, Pfizer
Barré syndrome, although it said data don’t prove a causal link and affirmed the shots’ benefit outweighs their risks.