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ODAC gives a big thumbs down to Oncopeptides’ dangling accelerated approval in multiple myeloma

ODAC on Thursday voted overwhelmingly against keeping the accelerated approval for Sweden-based Oncopeptides’ Pepaxto, voting 14 “no,” and 2 “yes” to the FDA’s question of: “is the benefit-risk profile of melphalan flufenamide favorable for the […]

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Guerbet Announces U.S. Food and Drug Administration (FDA) Approval of Elucirem™ (Gadopiclenol) Injection for Use in Contrast-Enhanced MRI

Elucirem™ has the highest relaxivity compared to other non-specific GBCAs 1 Elucirem™ requires only half the gadolinium dose of conventional non-specific GBCAs Elucirem™ will be manufactured in Raleigh, North Carolina by Liebel-Flarsheim™ Company LLC, a […]