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Stemline Therapeutics, Inc.

https://stemline.com/

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.

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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.

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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.

Deal Watch Business Strategies

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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