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Food and Drug Administration (FDA)

NEWS
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FDA
FDA Approves Eli Lilly’s Precision Oncology Treatment Retevmo for Certain Lung and Thyroid Cancers
Eli Lilly is moving quickly to get a newly-approved precision oncology treatment, Retevmo, for certain lung and thyroid cancers into the hands of patients.
May 11, 2020
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3 min read
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Alex Keown
FDA
FDA Grants Emergency Use Authorization for Rutgers’ At-Home COVID-19 Saliva Test
The new at-home saliva self-collection assay allows for broader screening than the standard and uncomfortable method using nose and throat swabs at a healthcare facility or testing location that requires a physical interaction with a healthcare professional.
May 8, 2020
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2 min read
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Alex Keown
FDA
FDA Action Alert: Blueprint, Bristol Myers Squibb, Clovis and Sunovion
Despite the COVID-19 pandemic, the U.S. Food and Drug Administration has managed to stay fairly on track in terms of evaluating new drug and supplemental new drug applications. Here’s a look at what’s on the schedule for the next two weeks.
May 8, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: May 8
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 8, 2020.
May 8, 2020
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5 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 7
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 7, 2020.
May 7, 2020
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5 min read
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BioSpace Editorial Staff
lucarista/Shutterstock
FDA
Tabrecta: FDA Gives Novartis Approval for First-Ever Therapy for NSCLC Tumors with METex14
Developed by Novartis, the drug, Tabrecta, is designed for a type of NSCLC that has spread to other parts of the body and cannot be removed by surgery.
May 6, 2020
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4 min read
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Gail Dutton
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FDA
FDA Approves AstraZeneca’s Farxiga for Heart Failure in Adults with Reduced Ejection Fraction
The drug can potentially reduce the risk of cardiovascular death and hospitalization for heart failure.
May 6, 2020
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3 min read
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Krystle Vermes
Policy
Biopharma Update on the Novel Coronavirus: May 6
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 6, 2020.
May 6, 2020
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5 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 5
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 5, 2020.
May 5, 2020
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6 min read
 · 
BioSpace Editorial Staff
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JOBS
IN THE PRESS
FDA
Nevakar Injectables Announces FDA Approval of Cyclophosphamide RTD Solution
July 3, 2023
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1 min read
Drug Development
Skyline Therapeutics Receives FDA Clearance of IND for SKG0106, a Novel Intravitreally Delivered AAV Gene Therapy Candidate for Neovascular Age-related Macular Degeneration
July 3, 2023
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2 min read
Policy
Cyltezo®, first and only FDA-approved Interchangeable biosimilar to Humira®, now commercially available in the U.S.
July 1, 2023
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12 min read
Policy
FDA Roundup: June 30, 2023
June 30, 2023
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4 min read
Policy
LumiraDx Submits First 510(k) Application to the FDA for COVID Ultra Test
June 30, 2023
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5 min read
Policy
Zealand Pharma submits New Drug Application to US FDA for dasiglucagon in congenital hyperinsulinism
June 30, 2023
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8 min read
FDA
FEops Receives FDA Clearance for Its AI-Based Anatomical Analysis Capabilities
June 30, 2023
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3 min read
FDA
FDA Approves ARUP Laboratories’ AAV5 DetectCDx™, a First-Ever Companion Diagnostic Immunoassay for a Gene Therapy
June 29, 2023
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5 min read
Policy
FDA Approves First Gene Therapy for Adults with Severe Hemophilia A
June 29, 2023
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4 min read
Policy
AVITA Medical Submits FDA PMA Supplement for RECELL GO
June 29, 2023
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4 min read
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