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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

Dupilumab lands expanded indication for upper airway disease

Study lays out common gaps in evidence both before and after approval

38% of patients treated with IL-13 blocker achieved clear or almost-clear skin at 16 weeks

Agency advisors put their foot down on shaky science for Ocaliva in primary biliary cholangitis

Designed for certain models, software can customize audio parameters

Clinicians should perform liver blood tests before and during Veozah treatment

In trials, guselkumab more than doubled remission rates versus placebo

Agency advisory panel to examine complicated efficacy data and liver safety concerns

Lawmakers also queried officials about a menthol cigarette rule and labeling of milk alternatives

Concerns about patient selection, antibiotic resistance dominated the discussion

New food ingredients are a "complete black box," one expert says