FDA Greenlights Avlayah (tividenofusp alfa-eknm) for Hunter Syndrome in Specific Patients on March 24
The FDA approved Avlayah (tividenofusp alfa-eknm) for treating neurologic Hunter syndrome in pediatric patients weighing at least 5 kg.
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DAILYZ HEALTH NEWS
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DAILYZ HEALTH NEWS
ALL ABOUT DAILYZ HEALTH NEWS
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FDA Approves Lifyorli (relacorilant) for Platinum-Resistant Ovarian Cancer on March 25
The FDA approved relacorilant (Lifyorli) with nab-paclitaxel for platinum-resistant ovarian cancer, based on improved progression-free survival in a phase 3 trial.
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Sotyktu (deucravacitinib) Awaits FDA Decision by March 6 for Adults with Active Psoriatic Arthritis
The FDA approved Sotyktu (deucravacitinib) on March 6, 2026, for adults with active psoriatic arthritis based on positive phase 3 trial results.
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FDA Approves Nivolumab Addition to AVD Chemotherapy for Patients 12 and Older with Hodgkin Lymphoma
The FDA approved nivolumab with AVD chemotherapy for patients 12+ with untreated Stage III/IV classical Hodgkin lymphoma.
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FDA Greenlights Nivolumab Plus AVD Regimen for Untreated Classic Hodgkin Lymphoma in March
The FDA approved nivolumab plus AVD for untreated Stage III/IV classical Hodgkin lymphoma in patients aged 12 and older.
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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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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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