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Tesaro Announces Opening of Niraparib Expanded Access Program for U.S. Patients With Ovarian Cancer
January 17, 2017 08:01 ET | TESARO, Inc.
WALTHAM, Mass., Jan. 17, 2017 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced the opening of an expanded access program (EAP) in the...
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Tesaro Announces Priority Review Designation for Niraparib NDA
December 20, 2016 08:00 ET | TESARO, Inc.
Niraparib New Drug Application accepted for review by FDA with a PDUFA goal date of June 30, 2017Niraparib Expanded Access Program (EAP) expected to open in U.S. in January 2017 WALTHAM, Mass., Dec. ...
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Tesaro Announces Submission of Niraparib New Drug Application for Platinum-Sensitive, Recurrent Ovarian Cancer
November 01, 2016 16:30 ET | TESARO, Inc.
WALTHAM, Mass., Nov. 01, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that it has completed the niraparib rolling New Drug...
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TESARO Announces Acceptance for Review of Niraparib Marketing Authorization Application by EMA
October 27, 2016 16:05 ET | TESARO, Inc.
WALTHAM, Mass., Oct. 27, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the Marketing Authorisation Application (MAA) for...
The Unmet Need in Ovarian Cancer
TESARO and ENGOT Announce Presentation of Successful Niraparib Phase 3 ENGOT-OV16/NOVA Trial Results During ESMO 2016
October 08, 2016 02:15 ET | TESARO, Inc.
Simultaneous presentation of data at ESMO and publication online in the New England Journal of MedicineTESARO Investor Webcast to be Held at 7:00 PM CET / 1:00 PM EDT COPENHAGEN, Oct. 08, 2016 ...
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TESARO Receives FDA Fast Track Designation for Niraparib and Initiates Rolling NDA Submission
September 12, 2016 08:01 ET | TESARO, Inc.
WALTHAM, Mass., Sept. 12, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has...
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TESARO Outlines Business Priorities and Strategic Outlook for 2016
January 11, 2016 08:15 ET | TESARO, Inc.
U.S. commercial launch of VARUBI™ (oral rolapitant) well underwayData from niraparib NOVA and QUADRA registration trials expected in Q2 2016 Niraparib New Drug Application (NDA) submission planned...