Stemline Therapeutics, Inc.
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Latest From Stemline Therapeutics, Inc.
CDER holds steady with a median time to approval of 11 months, while CBER posts 10.5 month median review time for its largest novel approvals class.
Scrip caught up with Olema CEO Sean Bohen ahead of a crucial combination data readout due this month for its novel SERD, palazestrant, which it hopes will put the drug on the path to a $10bn-plus breast cancer market.
Plus deals involving Sanofi/Adocia, Sirnaomics/EDIRNA, Eisai/DRI Healthcare, Sangamo/Voyager, Liquidia/Pharmosa, Tonix/Upsher-Smith and more.
The upcoming year could see a rebound approvals if the bigger-than-usual queue of novel agents with 2023 user fee goal dates pans out.
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