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 ...
Rigel Pharmaceuticals Gets FDA Orphan-Drug Designation for R289
Rigel Pharmaceuticals on Thursday said the U.S. Food and Drug Administration granted orphan-drug designation to its proposed R289 treatment for myelodysplastic syndromes, a group of rare blood cancers ...
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 ...
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 ...
Lead and cadmium found in muscle-building protein powders, report says
Protein powders may contain high levels of lead and cadmium, with chocolate-flavored and plant-based products testing at the ...
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 ...
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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 ...
JD Supra19h
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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Red dye could be banned in food, drinks
Red dye No. 3, used in drinks and snacks, could be banned by the U.S. Food and Drug Administration in the next few weeks, the ...
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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.