GSK Resubmits Tebipenem HBr NDA for Complicated UTIs After Phase 3 Non-Inferiority Data
GlaxoSmithKline resubmitted its NDA for tebipenem HBr to the FDA for complicated UTIs after positive Phase 3 non-inferiority trial results.
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ALL ABOUT DAILYZ HEALTH NEWS
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Gilead Submits NDA for Bulevirtide, First Potential HDV Treatment, Backed by Phase 3 MYR301 Data
Gilead Sciences submitted an NDA to the FDA for bulevirtide 10 mg to treat chronic hepatitis delta virus, supported by Phase 3 MYR301 data.
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FDA Extends Review of Reproxalap for Dry Eye Disease to March 16 Amid Clinical Study Requests
The FDA extended its review of Aldeyra’s reproxalap for dry eye disease to March 16, 2026, after requesting a clinical study report.
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FDA Approves Icotyde (icotrokinra) for Moderate-to-Severe Plaque Psoriasis in Patients 12 and Older
The FDA approved ICOTYDE (icotrokinra) for treating moderate-to-severe plaque psoriasis in patients 12 and older weighing at least 40 kg.
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FDA Clears ET-600 for Arginine Vasopressin Deficiency on February 25 PDUFA Date
Significant strides in pediatric care emerge as the FDA clears ET-600 for arginine vasopressin deficiency—discover what this means for treatment safety and outcomes.
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