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Food and Drug Administration (FDA)

NEWS
Stanford serology test is finally here.
FDA
Stanford Serology Test: Stanford Joins List of Organizations Offering COVID-19 Antibody Testing
The Stanford serology test provides results in two to three days and Stanford Health Care can test 500 samples per day. Know what more it has to offer.
April 13, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 10
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 10, 2020.
April 10, 2020
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7 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 9
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 9, 2020.
April 9, 2020
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9 min read
 · 
BioSpace Editorial Staff
FDA
FDA Approves Pfizer’s Braftovi Plus Cetuximab for Colorectal Cancer with BRAF Mutations
“We are pleased by the FDA’s approval of Braftovi in combination with cetuximab, as we are committed to developing targeted medicines that can help people living with certain mutation-driven cancers,” said Chris Boshoff, chief development officer, Oncology, Pfizer Global Product Development.
April 9, 2020
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2 min read
 · 
Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: April 8
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 8, 2020.
April 8, 2020
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7 min read
 · 
BioSpace Editorial Staff
Policy
Acceleron’s Clinical PAH Drug Wins Breakthrough Therapy Designation
The designation will allow the company to expedite the development and potential regulatory review of sotatercept.
April 8, 2020
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2 min read
 · 
Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: April 7
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 7, 2020.
April 7, 2020
 · 
6 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 6
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 6, 2020.
April 6, 2020
 · 
6 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: April 3
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 3, 2020.
April 3, 2020
 · 
6 min read
 · 
BioSpace Editorial Staff
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JOBS
IN THE PRESS
FDA
Anumana Receives U.S. FDA Breakthrough Device Designation for its Cardiac Amyloidosis Algorithm
June 21, 2023
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4 min read
Policy
Metavention’s Renal Denervation Pivotal IDE Study now Approved by FDA for the Treatment of Hypertension
June 21, 2023
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2 min read
Calliditas Therapeutics Submits Supplemental New Drug Application to U.S. Food and Drug Administration for Full Approval of TARPEYO®
June 21, 2023
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10 min read
Policy
FDA Roundup: June 20, 2023
June 20, 2023
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1 min read
FDA
Zynex Receives FDA Clearance of CM-1600 Monitor for Improved Blood and Fluid Management
June 20, 2023
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3 min read
FDA
Owlet Announces FDA-Clearance of the First Prescription Pulse Oximetry Sock for Infants
June 20, 2023
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2 min read
Genetown
Axena Health delivers at-home treatment for chronic fecal incontinence in women
June 20, 2023
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7 min read
FDA
U.S. FDA Approves First Anti-Inflammatory Drug for Cardiovascular Disease
June 20, 2023
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10 min read
Policy
ARS Pharmaceuticals Announces PDUFA Date Extension for neffy® (Intranasal (IN) Epinephrine) for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis
June 20, 2023
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6 min read
FDA
CSL Behring Announces the First Patient Has Received FDA-Approved HEMGENIX® (etranacogene dezaparvovec-drlb) for Hemophilia B
June 20, 2023
 · 
10 min read
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