FDA grants priority review to Bristol Myers Squibb's Iberdomide for multiple myeloma
Iberdomide has the potential to be the first approved CELMoD agent
Iberdomide has the potential to be the first approved CELMoD agent
Ind-Ra expects chronic therapies to outpace IPM as compliance improves and lifestyle diseases rise
MYC, a master regulator of oncogenic transcription, drives multiple high-burden cancers but has long eluded direct pharmacologic control
PreemieFort Enteral Solution's approval marks the first time a nutritional product derived from human milk has been recognized as a prescription medicine anywhere in the world
The approval marks a major advance in targeted treatment for this rare, chronic autoimmune disease, offering twice-yearly maintenance dosing after two initial loading doses
Achondroplasia is a genetic condition driven by FGFR3 that affects more than stature alone
This approval represents the seventh FDA-approved companion diagnostic indication for PD-L1 IHC 22C3 pharmDx with KEYTRUDA
The FDA’s Center for Biologics Evaluation and Research (CBER) cited Moderna’s choice of a licensed standard-dose flu vaccine as the comparator in its Phase 3 trial, saying it “does not reflect the best-available standard of care.”
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