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Food and Drug Administration (FDA)

NEWS
FDA
FDA Approves 1st COVID-19 Antibody Test
The U.S. Food and Drug Administration approved the first blood test that looks for the antibodies against the novel coronavirus that causes COVID-19.
April 3, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 2
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 2, 2020.
April 2, 2020
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7 min read
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BioSpace Editorial Staff
Policy
As COVID-19 Cases Rise, FDA Accelerates Development of Therapies
The U.S. Food and Drug Administration is expediting the development of novel therapies for the pandemic through an accelerated evaluation process.
April 1, 2020
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2 min read
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Alex Keown
photobyphm/Shutterstock
Policy
FDA Ends Zolgensma Data Manipulation Investigation, Places No Penalties on Novartis
In a statement, the FDA said “objectionable conditions were found and documented” but did not meet the threshold for regulatory action against the Swiss pharma giant.
April 1, 2020
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2 min read
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Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: March 31
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 31, 2020.
March 31, 2020
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7 min read
 · 
BioSpace Editorial Staff
FDA
Amidst Controversy, FDA Issues EUA Allowing Anti-Malaria Drugs to Be Used to Treat COVID-19
Scientists and physicians have been cautious about use of the drug for the disease, while President Trump touted it as a “game changer.”
March 30, 2020
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4 min read
 · 
Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: March 30
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 30, 2020.
March 30, 2020
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5 min read
 · 
BioSpace Editorial Staff
Policy
FDA Action Alert: Bristol Myers Squibb, Acceleron and UroGen
Here’s a look at the next two target action dates on the calendar for early April.
March 27, 2020
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3 min read
 · 
Mark Terry
Drug Development
Biopharma Industry News for March 27: Update on the Novel Coronavirus
A summary of daily biopharma industry news. Please check out stories that are trending on March 27, 2020.
March 27, 2020
 · 
3 min read
 · 
BioSpace Editorial Staff
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JOBS
IN THE PRESS
FDA
Surmodics Receives FDA Approval for the SurVeil™ Drug-Coated Balloon
June 20, 2023
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6 min read
FDA
FDA Approves Innovative 4D Flow MRI Blood Flow Analysis Software from Cardio Flow Design Inc. (Japan) - Enhance Cardiovascular Diagnostic Accuracy
June 19, 2023
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3 min read
Genetown
Seres Therapeutics and Nestlé Health Science Present Late-Breaking Data on VOWST™, a Microbiota-Based Oral Therapeutic for Prevention of Recurrence of C. Difficile Infection in Adults, at ASM Microbe 2023
June 17, 2023
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7 min read
Policy
IASO Bio Receives FDA Approval of IND Application for IASO-782 for Treatment of Autoimmune Disease
June 17, 2023
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4 min read
Policy
FDA Roundup: June 16, 2023
June 16, 2023
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6 min read
Policy
Biotech Executive Michael Smith Discusses the FDA Drug Development Process with CancerVAX CEO Ryan Davies
June 16, 2023
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3 min read
Drug Development
U.S. Food and Drug Administration Approves Addition of Positive Data from Phase 3 VALOR-HCM Study to CAMZYOS® (mavacamten) Label
June 15, 2023
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21 min read
Policy
FDA Approves Genentech’s Columvi, the First and Only Bispecific Antibody With a Fixed-Duration Treatment for People With Relapsed or Refractory Diffuse Large B-cell Lymphoma
June 15, 2023
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24 min read
Policy
Reata Pharmaceuticals Announces FDA Filing Acceptance of SKYCLARYS® (Omaveloxlone) NDA Prior Approval Supplement
June 15, 2023
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3 min read
BioCapital
Novavax Prepared to Deliver Protein-based Monovalent XBB COVID Vaccine Consistent with FDA VRBPAC Recommendation for the Fall
June 15, 2023
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8 min read
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