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FDA approves GSK’s Wellcovorin for cerebral folate deficiency
FDA worked with GSK to update Wellcovorin labelling for safe, effective use in adult and paediatric CFD-FOLR1 patients.
FDA’s CRLs reveal critical errors in AstraZeneca’s Saphnelo data, efficacy doubts for GSK’s Exdensur
In a scathing rebuke (PDF) to AstraZeneca, the FDA cited “critical data quality issues that affect key analyses, including the primary endpoint” within a dataset for Saphnelo (anifrolumab) for the ...
Inluriyo, an oral estrogen receptor antagonist, significantly reduced disease progression risk in ESR1-mutated metastatic breast cancer, as shown in the EMBER-3 trial. Keytruda Qlex, a subcutaneous ...
Stoboclo and Osenvelt were approved as interchangeable biosimilars for bone loss conditions, potentially reducing costs and increasing access. Darzalex Faspro was approved for high-risk smoldering ...
FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...
The FDA approved Dupixent as the first treatment for allergic fungal rhinosinusitis in adults and children over six years old with prior sinus surgery. A 52-week trial showed improved symptoms and ...
Not long after Novo Nordisk received an untitled letter from the FDA disputing certain elements of the first TV spot for its ...
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