TESARO Announces Fourth-Quarter 2016 Operating Results
February 28, 2017 16:05 ET
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TESARO, Inc.
Niraparib NDA under review by FDA; pre-launch preparations for planned commercial launch well underwayExpanded access program (EAP) for niraparib open in U.S.; European EAP expected to open 1H...
Tesaro Announces Opening of Niraparib Expanded Access Program for U.S. Patients With Ovarian Cancer
January 17, 2017 08:01 ET
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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...
Tesaro Announces Priority Review Designation for Niraparib NDA
December 20, 2016 08:00 ET
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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. ...
Tesaro Announces Submission of Niraparib New Drug Application for Platinum-Sensitive, Recurrent Ovarian Cancer
November 01, 2016 16:30 ET
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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...
TESARO Announces Acceptance for Review of Niraparib Marketing Authorization Application by EMA
October 27, 2016 16:05 ET
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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...
TESARO and ENGOT Announce Presentation of Successful Niraparib Phase 3 ENGOT-OV16/NOVA Trial Results During ESMO 2016
October 08, 2016 02:15 ET
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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 ...
TESARO Receives FDA Fast Track Designation for Niraparib and Initiates Rolling NDA Submission
September 12, 2016 08:01 ET
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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...
TESARO Outlines Business Priorities and Strategic Outlook for 2016
January 11, 2016 08:15 ET
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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...