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Food and Drug Administration (FDA)

NEWS
Policy
Biopharma Update on the Novel Coronavirus: July 31
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 31, 2020.
July 30, 2020
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4 min read
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BioSpace Editorial Staff
Policy
Solid Biosciences’ DMD Gene Therapy Remains on Clinical Hold
The IGNITE DMD study is assessing the company’s microdystrophin gene therapy asset SGT-001 as a potential treatment for DMD.
July 27, 2020
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2 min read
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Alex Keown
Oxbryta gets greenlight for Pediatric SCD treatmen
FDA
FDA Greenlights Gilead/Kite’s Tecartus for Mantle Cell Lymphoma
The U.S. Food and Drug Administration (FDA) approved Kite Pharma’s Tecartus (brexucabtagene autoleucel) for adults with relapsed or refractory mantle cell lymphoma (MCL). Kite is a Gilead Science company.
July 24, 2020
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3 min read
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Mark Terry
Policy
As FDA Approaches Next PDUFA Iteration, Industry Offers its Wish List
The Prescription Drug User Fee Act (PDUFA) was first passed into law by the U.S. Congress in 1992.
July 24, 2020
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3 min read
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Mark Terry
FDA
AstraZeneca Wins FDA Approval for COPD Treatment
This morning, AstraZeneca announced the approval of the triple-therapy Breztri Aerosphere as a maintenance treatment for COPD.
July 24, 2020
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2 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: July 24
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 24, 2020.
July 23, 2020
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4 min read
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Editorial Staff
FDA
Jazz Pharma Wins FDA Approval for Lower-Sodium Narcolepsy Treatment
The U.S. Food and Drug Administration (FDA) approved Xywav, the first new treatment option indicated for both cataplexy and excessive daytime sleepiness in people living with narcolepsy in more than 15 years.
July 22, 2020
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2 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: July 22
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 22, 2020.
July 21, 2020
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6 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 20
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 20, 2020.
July 20, 2020
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2 min read
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BioSpace Editorial Staff
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JOBS
IN THE PRESS
Policy
BioCity announces FDA clearance of Investigational New Drug application for its first-in-class CD3/EGFR bispecific antibody
August 7, 2023
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2 min read
Policy
VenusP-Valve granted IDE approval for clinical trial, unveiling a new chapter for Chinese valve solutions globally
August 6, 2023
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3 min read
Policy
FDA Approves ZURZUVAE™ (zuranolone), the First and Only Oral Treatment Approved for Women with Postpartum Depression, and Issues a Complete Response Letter for Major Depressive Disorder
August 4, 2023
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18 min read
FDA
FDA Approves First Oral Treatment for Postpartum Depression
August 4, 2023
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3 min read
Policy
FDA Roundup: August 4, 2023
August 4, 2023
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4 min read
Drug Development
ImPact Biotech receives FDA Clearance for Padeliporfin VTP Phase 1 Clinical Program in Peripheral Lung Cancer
August 4, 2023
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4 min read
FDA
Biosense Webster Receives FDA Approval for Multiple Atrial Fibrillation Ablation Products to be Used in a Workflow Without Fluoroscopy
August 4, 2023
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8 min read
Policy
Basilea announces submission of a New Drug Application to the US Food and Drug Administration for its antibiotic ceftobiprole
August 4, 2023
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6 min read
Policy
Mesoblast Receives Complete Response From U.S. Food and Drug Administration for Biologics License Application for Steroid-Refractory Acute Graft Versus Host Disease in Children
August 3, 2023
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9 min read
Drug Development
Aardvark Therapeutics Announces Receipt of FDA Rare Pediatric Disease Designation for Prader-Willi Syndrome and Expands the Ongoing Phase 2 Clinical Trial
August 3, 2023
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3 min read
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