FDA’s Anti-Infective Drugs Advisory Committee will review Oscient’s sNDA for the antibiotic Sept. 12.
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Testimony during a July 21 ‘expert panel’ could help justify stronger warnings across the class about potential adverse effects on mother and baby. Panelists ranged from clinicians who said depression during pregnancy should be treated, to those who said sadness has been “medicalized."
The European Medicines Agency has started reviewing for potential EU marketing approval six new products, including MaaT Pharma’s microbiota therapeutic for acute-graft-versus-host disease, and AstraZeneca's camizestrant for locally advanced or metastatic breast cancer.
The European Medicines Agency has revised the sponsor handbook for the Clinical Trials Information System, bringing together guidance that was previously scattered across multiple platforms and documents to help sponsors navigate the trial process more efficiently.
