Keeping Track: Parsaclisib, Kymriah Applications Target Non-Hodgkin Lymphomas; AbbVie Gets New Use For Old Ophthalmic
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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New EU Filings Include Tibsovo Resubmission, Pegunigalsidase & Daprodustat
Servier is trying again with Tibsovo in the EU, while Protalix is using June 2021 data to support its filing for pegunigalsidase, which the US regulator turned down last April.
Keeping Track Of Withdrawals: Libtayo, Parsaclisib Applications Pulled Due To Postmarketing Issues
Changing therapeutic landscape may have complicated regulatory plans for Regeneron/Sanofi’s PD-1 inhibitor in second-line cervical cancer, while accelerated approval confirmatory trial timeline appears to have been an issue for Incyte’s PI3-kinase inhibitor in lymphoma.
With Vuity Approval, AbbVie Continues Stepping Into Eye Care
AbbVie had no presence in ophthalmic medicine other than a single indication for Humira before the Allergan merger, but now has a growing eye care portfolio, including early FDA approval of Vuity for presbyopia.