TESARO Announces Fourth-Quarter 2016 Operating Results
28 févr. 2017 16h05 HE
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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
17 janv. 2017 08h01 HE
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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
20 déc. 2016 08h00 HE
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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 Acceptance for Review of Niraparib Marketing Authorization Application by EMA
27 oct. 2016 16h05 HE
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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
08 oct. 2016 02h15 HE
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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
12 sept. 2016 08h01 HE
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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
11 janv. 2016 08h15 HE
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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...