Stemline Therapeutics, Inc.
https://stemline.com/
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Latest From Stemline Therapeutics, Inc.
Consistency, Not Fireworks: US FDA’s Novel Approvals Times Stick Close To PDUFA Schedule
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.
Olema Boosts Its Partnering Position With SERD Combo Data
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.
Deal Watch: Takeda Calls Upon The UK’s F-star Again For Bispecific Candidates
Plus deals involving Sanofi/Adocia, Sirnaomics/EDIRNA, Eisai/DRI Healthcare, Sangamo/Voyager, Liquidia/Pharmosa, Tonix/Upsher-Smith and more.
Bountiful Approvals May Be Ahead As FDA Starts 2023 With Almost 60 Novel Agents Under Review
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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