FDA to Review GRAIL’s Galleri Multi-Cancer Blood Test at September Advisory Meeting
GRAIL’s Galleri cancer blood test will be reviewed by FDA experts as the company seeks full approval for early cancer detection.
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#XY Event-Driven Stocks↓
FDA Completes First-Cycle Review of NRx’s Ketamine ANDA with No Drug-Related Issues
FDA clears path for NRx’s preservative-free ketamine: no major drug issues found, only packaging certification remains.
Tarsus to Acquire Alkeus in Up to $800 Million Deal for Rare Eye Disease Drug
Tarsus to acquire Alkeus for up to $800M, adding late-stage oral therapy for Stargardt disease – a rare eye disorder with no approved treatments.
FDA Approves ORZEYFUL: First Medicine to Treat the Root Cause of Narcolepsy Type 1
Twice-daily pill improves wakefulness and reduces symptoms.
Moderna’s mFlusiva Becomes First mRNA Flu Shot Cleared by FDA
FDA approves mFlusiva, Moderna’s first mRNA flu vaccine for adults 50+. Available soon for the 2026 season with strong trial results.
Sight Sciences Stock Jumps After FDA Clears New OMNI Ultra Glaucoma Device
Sight Sciences gets FDA clearance for OMNI Ultra, the first single-pass implant-free MIGS device for glaucoma.