Keeping Track: Merck & Co. In Spotlight With Welireg, Keytruda Approvals; FibroGen/AZ Roxadustat CRL Is No Surprise
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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A review of drugs and supplemental uses since the project’s inception shows roughly one-third of the products reviewed have been NMEs.
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.
Ipsen has withdrawn the US NDA for palovarotene in an ultra-rare bone condition in order to conduct additional data analyses, but intends to resubmit once they are complete.