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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.

FDA Completes First-Cycle Review of NRx’s Ketamine ANDA with No Drug-Related Issues
Credit: NRx Pharmaceuticals
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08/07/2026 · 9:53 AM
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FDA Approves First SMA Drug That Targets Muscle Loss, Not Just Nerves
Featured/ 09/11/2026 · 5:55 PM

FDA Approves First SMA Drug That Targets Muscle Loss, Not Just Nerves

The FDA approved Scholar Rock’s Isembyld, the first SMA therapy aimed at muscle wasting in patients already on nerve-targeted treatment.

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AstraZeneca’s Etcamah Combination Falls Short of Statistical Significance in SERENA-4
Featured/ 09/11/2026 · 4:48 PM

AstraZeneca’s Etcamah Combination Falls Short of Statistical Significance in SERENA-4

The Phase III SERENA-4 trial did not meet its primary PFS endpoint in untreated advanced ER-positive, HER2-negative breast cancer, despite a numerical benefit.

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Citi Says AppLovin Is Positioned to Meet or Beat Q3 Guidance
09/11/2026 · 4:30 PM

Citi Says AppLovin Is Positioned to Meet or Beat Q3 Guidance

Citi added a 90-day upside view on AppLovin with a $600 target, calling Q3 concerns misguided.

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