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Keeping Track: Merck & Co. In Spotlight With Welireg, Keytruda Approvals; FibroGen/AZ Roxadustat CRL Is No Surprise

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

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Project Orbis Nears 30 Approvals In Oncology; Could China Be Added?

A review of drugs and supplemental uses since the project’s inception shows roughly one-third of the products reviewed have been NMEs.

Merck’s Welireg Gets Orphan Pricing Ahead Of Broader RCC Indications

The company set a $26,400 per month list price for the HIF-2α inhibitor in its first US FDA-approved indication of VHL disease-associated tumors, but the drug is being studied in broader populations.

Further Analyses To Delay Ipsen’s Palovarotene Progress In Ultra-Rare Disease

Ipsen has withdrawn the US NDA for palovarotene in an ultra-rare bone condition in order to conduct additional data analyses, but intends to resubmit once they are complete.

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