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Food and Drug Administration (FDA)

NEWS
Policy
Biopharma Update on the Novel Coronavirus: May 27
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 27, 2020.
May 27, 2020
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4 min read
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BioSpace Editorial Staff
FDA
BMS’ Opdivo and Yervoy Combination Treatment Snags Two Approvals in Lung Cancer this Month
Bristol Myers Squibb is doing its best to claim market share in the checkpoint inhibitor space and over the past month, the company is pushing its way forward with a pair of regulatory approvals in lung cancer.
May 27, 2020
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2 min read
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Alex Keown
FDA
Sanofi and Regeneron’s Dupixent Scores Another Approval for Dermatitis, This Time in Kids
To date, Dupixent is the only biologic approved for this age group.
May 26, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: May 26
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 26, 2020.
May 26, 2020
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4 min read
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BioSpace Editorial Staff
Kynmobi got approved stamp from FDA
FDA
FDA Gives Thumbs-Up to Sunovion’s Under-the-Tongue Parkinson’s Drug Kynmobi
“Today’s approval of Kynmobi advances treatment options for people with Parkinson’s disease who experience OFF episodes and the associated disruption of everyday activities,” said Antony Loebel, Sunovion’s president and chief executive officer.
May 22, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: May 22
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 22, 2020.
May 22, 2020
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4 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 21
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 21, 2020.
May 21, 2020
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4 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 20
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 20, 2020.
May 20, 2020
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6 min read
 · 
BioSpace Editorial Staff
FDA
Lynparza Becomes Second PARP Inhibitor Approved for Prostate Cancer, Just Days Behind the First
Clovis Oncology’s Rubraca remained the only PARP inhibitor approved for prostate cancer for only a handful of days. Today, that medication is joined by AstraZeneca’s and Merck’s powerhouse PARP inhibitor, Lynparza.
May 20, 2020
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3 min read
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Alex Keown
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IN THE PRESS
Policy
FDA Roundup: July 11, 2023
July 11, 2023
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2 min read
FDA
Gene Therapy Company Genprex, Inc. (NASDAQ: GNPX) Receives Fast Track Designation From The FDA For Its Small Cell Lung Cancer Drug Candidate
July 11, 2023
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1 min read
FDA
AccurKardia’s AccurECG™ Analysis System Receives FDA 510(k) Clearance
July 11, 2023
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3 min read
Drug Development
Renibus Therapeutics Announces Breakthrough Therapy Designation from US FDA for RBT-1 for the Reduction in Risk of Post-Operative Complications in Patients Undergoing Cardiothoracic Surgery
July 11, 2023
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3 min read
Policy
Synlogic Granted Fast Track Designation from FDA for labafenogene marselecobac (SYNB1934) for Treatment of Phenylketonuria
July 11, 2023
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5 min read
Policy
Better Therapeutics Receives FDA Authorization for AspyreRx™ to Treat Adults with Type 2 Diabetes
July 10, 2023
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9 min read
FDA
MyoPax Receives Rare Pediatric Disease Designation from FDA for Breakthrough Regenerative Cell Product in Exstrophy-Epispadias Complex
July 10, 2023
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2 min read
FDA
US FDA approves expanded indication for Novartis Leqvio® (inclisiran) to include treatment of adults with high LDL-C and who are at increased risk of heart disease
July 10, 2023
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10 min read
Policy
Hemogenyx Pharmaceuticals PLC Announces Full FDA Review for HEMO-CAR-T IND
July 10, 2023
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3 min read
Policy
FDA Roundup: July 7, 2023
July 7, 2023
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4 min read
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