Keeping Track: US FDA Approval Binge Includes Brexafemme, Wegovy, Ryplazim, Truseltiq, Lybalvi, Tembexa
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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US FDA, Foundation for the NIH, and NCI are considering a new PPP aimed at creating a repeatable process for development of drugs to treat ultra-rare cancers where commercial viability is lacking. Stakeholders say industry incentives, IP issues and reimbursement need attention.
BridgeBio and US FDA agreed on a path to accelerated approval for BB-418, a Phase III oral candidate for a subset of limb-girdle MD patients. If successful, it would bring BridgeBio’s third product to market.
The FGFR inhibitor beats prior entrants on efficacy in cholangiocarcinoma, although Relay presented data at ESMO for its investigational RLY-4008 showing especially high efficacy and tolerability.