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- Tarver: CDRH on a ‘recruiting tear,’ looking ahead to MDUFA VIBOSTON – Top US Food and Drug Administration (FDA) medical device officials said they are focused on restaffing after last year’s reduction-in-force (RIF) and are optimistic about the Medical Devic…raps · 23h ago↗ source
- Drugmakers urge FDA take more flexible approach to container closure testingMajor pharmaceutical companies are urging the US Food and Drug Administration (FDA) to adopt a more flexible, risk-based approach in its guidance on testing container-closure systems (CCS) for drug…raps · 23h 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,…