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More in FDA General
Despite problematic dataset, risk/benefit profile not favorable with PD-L1 expression below 1
Phase III trial program showed 30% to 34% reduction in moderate or severe exacerbations
Xanomeline and trospium chloride (Cobenfy) has no boxed warnings
Benefits of voxelotor (Oxbryta) no longer outweigh the risks, Pfizer says
EGFR inhibitor now indicated for unresectable stage III disease following chemoradiotherapy
FDA approves levacetylleucine (Aqneursa) for Niemann-Pick disease type C
Decoding recent SCOTUS decisions and their potential impact on healthcare
Data since approvals suggest benefits limited to subgroups with PD-L1 expression of at least 1%
FluMist nasal spray can now be used without the help of a healthcare provider
Arimoclomol (Miplyffa) greenlit for ultra-rare genetic disorder
Drugmaker none-too-pleased with agency's request for additional studies
Benralizumab wins approval for eosinophilic granulomatosis with polyangiitis
Broad indication doubles the number of patients eligible for adjuvant CDK4/6 inhibition
Agency sounds alarm that products still may contain amniotic fluid
