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BioSpace News Archive
Browse BioSpace’s published news and press releases by year, month, and day.
207 Results
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FDA
US FDA Approves TAGRISSO® (osimertinib) As 1st-Line Treatment For EGFR-Mutated Non-Small Cell Lung Cancer
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved TAGRISSO® (osimertinib) for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) mutations (exon 19 deletions or exon 21 L858R mutations), as detected by an FDA-approved test.
April 18, 2018
·
11 min read
FDA
Roche expands indication for cobas® EGFR Mutation Test v2 as a companion diagnostic with TAGRISSO®
Roche announced it has received approval from the U.S. Food and Drug Administration (FDA) of its Premarket Approval (PMA) supplement for the cobas® EGFR Mutation Test v2 to be used as a companion diagnostic test (CDx) with TAGRISSO® for first line treatment of patients diagnosed with metastatic NSCLC whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations.
April 18, 2018
·
4 min read
Biotech Bay
Silicon Microstructures’ IntraSenseTM Calibrated Simplifies In Vivo Pressure Measurements
SMI is excited to announce its continued leadership and innovation in the in vivo pressure measurement space.
April 18, 2018
·
2 min read
Drug Development
Evotec and Bayer Advance Third Endometriosis Programme into Phase I Clinical Development
Milestone achieved under the highly successful strategic alliance Evotec and Bayer entered in October 2012.
April 18, 2018
·
4 min read
FDA
NeuroVive’s KL1333 Receives FDA Orphan Drug Designation for Treatment of Mitochondrial Diseases
Orphan drug designation will give the KL1333 program extra access to regulatory and scientific advice and interactions at the FDA
April 18, 2018
·
4 min read
Business
Sempre Health and Novo Nordisk Partner to Improve Medication Costs for Patients With Diabetes
Sempre works with health plans to reward their membership’s positive choices and actions.
April 18, 2018
·
2 min read
BioCapital
MAXIMUS Contact Centers in Georgia and New Jersey Awarded by BenchmarkPortal
MAXIMUS announced that its customer contact center operations in Georgia and New Jersey have received the 2018 Top Contact Center Award in five different categories by BenchmarkPortal, Inc.
April 18, 2018
·
3 min read
Biotech Bay
BioCardia Presents at Alliance for Regenerative Medicine’s (ARM’s) Annual Cell & Gene Therapy Investor Day
BioCardia is a leader in cardiovascular regenerative medicine.
April 18, 2018
·
2 min read
Business
Canopy Growth Corporation enters into supply agreement with the Yukon Liquor Corporation
Canopy Growth Corporation and the Yukon Liquor Corporation announced that the Company has entered into an agreement to supply Yukon with high-quality cannabis products to serve the upcoming adult retail market.
April 18, 2018
·
3 min read
Policy
British MP Benn Talks Brexit Challenges and the Future of UK Clinical Research Industry
Facing unprecedented challenges associated with Brexit, on 13 April the UK’s major clinical research organizations (CROs) met with the Rt Hon Hilary Benn (Labour - Leeds Central) to tour Covance’s research facilities in Leeds and discuss the implications of the impending separation from the European Union.
April 18, 2018
·
2 min read
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