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1. www.fdatracker.com › fda-calendarFDA Calendar – FDA Tracker

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   Our enhanced FDA calendar integrates PDUFA dates, clinical trial primary completion dates, and working capital runway estimates into a single timeline that covers companies publicly traded in the U.S. facing upcoming PDUFA dates.

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2. www.nasdaq.com › press-release › sesen-bio-announces-anticipated-regulatory-pathSesen Bio Announces Anticipated Regulatory Path Forward for ... -...

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   8 gru 2021 · In February 2021, the FDA accepted the Company’s Biologics License Application (BLA) file for Vicineum for the treatment of BCG-unresponsive NMIBC, granted Priority Review for the BLA and set a...

3. seekingalpha.com › article › 4425611-sesen-bio-long-short-term-potential-inSesen Bio: Long-Term And Short-Term Potential In Advance Of Its...

   seekingalpha.com › article › 4425611-sesen-bio-long-short-term-potential-in

   7 maj 2021 · Sesen Bio is seeking an accelerated approval for its NMIBC therapy, Vicineum, and the PDUFA date is coming up soon on Aug. 18.

4. www.biospace.com › sesen-bio-submits-marketing-authorization-application-to-theSesen Bio Submits Marketing Authorization Application to the ......

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   8 mar 2021 · In February 2021, the FDA accepted for filing the Company’s BLA for Vicineum for the treatment of high-risk, BCG-unresponsive NMIBC and granted the application Priority Review with a Prescription Drug User Fee Act (PDUFA) date of August 18, 2021.

5. www.biospace.com › article › releasesSesen Bio Announces Anticipated Regulatory Path Forward for ... -...

   www.biospace.com › article › releases

   9 gru 2021 · Sesen Bio today announced its anticipated regulatory path forward for Vicineum™ or the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) following its Clinical Type A meeting with the US Food and Drug Administration (FDA), which occurred on December 8, 2021 (Clinical Type A Meeting).

6. www.businesswire.com › news › homeSesen Bio Announces Significant Commercial Progress as the...

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   26 lip 2021 · In February 2021, the FDA accepted for filing the Company’s BLA for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of...

7. www.biospace.com › sesen-bio-announces-fda-acceptance-and-priority-review-of-itsSesen Bio Announces FDA Acceptance and Priority Review of ... -...

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   16 lut 2021 · In February 2021, the FDA accepted for filing the Company’s BLA for Vicineum for the treatment of high-risk, BCG-unresponsive NMIBC and granted the application Priority Review with a PDUFA date of August 18, 2021. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may ...