Novo Nordisk’s Oral Wegovy Gains FDA Approval, 25mg Semaglutide Tablet Launches for Weight Management
The FDA approved Novo Nordisk’s 25 mg oral Wegovy semaglutide tablet for adult weight management, launching in January 2026.
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DAILYZ HEALTH NEWS
ALL ABOUT DAILYZ HEALTH NEWS
DAILYZ HEALTH NEWS
ALL ABOUT DAILYZ HEALTH NEWS
FDA
ASH Highlights PDUFA Dates for Subcutaneous Istuximab in Myeloma, CAR T-Cell Therapy for AML/ALL/MDS
The FDA set an April 23, 2026 PDUFA date for subcutaneous isatuximab in relapsed/refractory multiple myeloma, following positive phase 3 trial results.
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FDA Proposes Reclassifying Mycobacterium Tuberculosis Immunity Tests to Class II Devices
The FDA proposed reclassifying Mycobacterium tuberculosis immunity tests from Class III to Class II devices with new special controls.
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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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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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