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- FDA approves AstraZeneca breast cancer drug despite negative advisory committee vote; Novartis faces cholesterol drug setbacksThe U.S. Food and Drug Administration granted approval to AstraZeneca's breast cancer therapy even though the advisory committee voted against it. The decision underscores the agency's willingness…
- EMA publishes guidance on voluntary electronic product information submissions for EU MAAsThe European Medicines Agency released new guidance detailing how companies should provide electronic product information (ePI) when filing marketing authorization applications under the EU's centr…raps · 4d agoRegulatoryNeutral