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- FDA accuses Baxter leaders of ‘inadequate’ oversight after finding GMP failingsThe recurrence of violations at multiple sites led the FDA to conclude that Baxter management must improve its oversight and control of manufacturing.BioSpace · 43m ago↗ source
- Genmab faces steep revenue cliff as Darzalex patents expire, eyes pivotal Epkinly readoutGenmab relies heavily on Darzalex, a cancer drug co‑developed with Johnson & Johnson, which currently provides about 90% of the company’s sales. U.S. patents for Darzalex are set to expire in 2029,…
- Rapport Therapeutics reports Phase 2 success for RAP-219 in bipolar mania trial