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US FDA Performance Tracker Drug Review Approvals

Keeping Track: Submissions Galore Start The New Year; US FDA Clears New Indications For Enhertu, Xalkori

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The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker

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Accelerated Approval: US FDA Review Of Expedited Program Could Bring More Withdrawals

Oncology Center of Excellence’s ‘industry-wide evaluation’ of accelerated approvals leads to removal of indications for two PD-1/L-1 inhibitors, AstraZeneca’s Imfinzi and Bristol-Myers Squibb’s Opdivo, both of which had failed confirmatory trials.

Finance Watch: Argenx Raises $1.15bn For Efgartigimod Commercialization

Public Company Edition: Among other recent large financings, BridgeBio Pharma launched a $650m note sale, CureVac closed a $517.5m follow-on offering and Revolution Medicines raised $260.9m.

Keeping Track: US FDA Has Clinical Questions For Tricida, Gilead And BioMarin; Enspryng And Winlevi Approved

The latest drug approval and decision news from the Pink Sheet’s US FDA Performance Tracker.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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