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28 results
10:22 PM, Jan 18, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA approves AZ's Lynparza for breast cancer

of discontinuations in the chemotherapy arm. Concurrent with Lynparza's approval, FDA approved Lynparza's companion diagnostic BRACAnalysis
5:29 PM, Oct 19, 2017  |  BC Week In Review | Clinical News  |  Regulatory

AZ's Lynparza gets Priority Review for breast cancer

to treat ovarian cancer. Concurrently, FDA accepted for review an sPMA for Lynparza companion diagnostic BRACAnalysis
12:00 AM, Oct 31, 2016  |  BC Week In Review | Clinical News  |  Clinical Results

Lynparza olaparib: Phase III data

submission plans with FDA. Patients were screened for germline BRCA mutations in SOLO-2 using the BRACAnalysis
12:00 AM, Oct 17, 2016  |  BC Week In Review | Clinical News  |  Clinical Results

Niraparib: Additional Phase III data

2 diagnostics from Myriad Genetics Inc. (NASDAQ:MYGN, Salt Lake City, Utah) in the trial: the BRACAnalysis
12:00 AM, Feb 02, 2015  |  BC Week In Review | Clinical News  |  Regulatory

Tumor BRACAnalysis CDx regulatory update

Myriad Genetics received CE Mark approval for Tumor BRACAnalysis CDx to detect breast cancer 1 early …
response to platinum-based chemotherapy. Myriad Genetics Inc. (NASDAQ:MYGN), Salt Lake City, Utah   Product: Tumor BRACAnalysis
12:00 AM, Dec 22, 2014  |  BC Week In Review | Clinical News  |  Regulatory

Lynparza olaparib regulatory update

FDA concurrently approved a PMA from Myriad Genetics Inc. (NASDAQ:MYGN, Salt Lake City, Utah) for BRACAnalysis
12:00 AM, Dec 22, 2014  |  BC Week In Review | Clinical News  |  Regulatory

BRACAnalysis CDx regulatory update

FDA approved a PMA from Myriad for BRACAnalysis CDx as the only companion diagnostic for ovarian …
boundaries of the breast cancer 1 early onset (BRCA1) and BRCA2 genes from whole blood. BRACAnalysis
complete response or partial response to platinum-based chemotherapy. Myriad is seeking CE Mark approval of BRACAnalysis
12:00 AM, Jun 30, 2014  |  BC Week In Review | Clinical News  |  Regulatory

Olaparib regulatory update

City, Utah) submitted the first of 4 modules of a PMA to FDA for its BRACAnalysis
test as a companion diagnostic for olaparib. Myriad markets BRACAnalysis to assess a woman’s risk of …
12:00 AM, May 12, 2014  |  BC Week In Review | Clinical News  |  Clinical Status

Niraparib: Phase III started

from Merck (see BioCentury, June 11, 2012). Under a June 2013 deal, Tesaro will use BRACAnalysis
to respond to niraparib for enrollment in Phase III trials of the product. Myriad markets BRACAnalysis

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