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Approvals

FDA
FDA Approves Lilly’s Tauvid Imaging Agent to Help Diagnose Alzheimer’s Disease
Tauvid is the first and only approved diagnostic agent for imaging tau neurofibrillary tangles (NFTs) in the brain.
May 29, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: June 1
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 1, 2020.
May 28, 2020
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3 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: May 29
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 29, 2020.
May 28, 2020
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2 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 28
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 28, 2020.
May 28, 2020
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6 min read
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BioSpace Editorial Staff
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
 · 
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
 · 
BioSpace Editorial Staff
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PRESS RELEASES
FDA
Dizal Pharmaceutical Receives U.S. FDA Fast Track Designation for DZD4205 (Golidocitinib) for the Treatment of Refractory or Relapsed Peripheral T-Cell Lymphoma
February 18, 2022
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3 min read
FDA
AVITA Medical Announces FDA Approval of New RECELL® System with Improved Ease of Use
February 17, 2022
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6 min read
FDA
Agios Announces FDA Approval of PYRUKYND® (mitapivat) as First Disease-Modifying Therapy for Hemolytic Anemia in Adults with Pyruvate Kinase Deficiency
February 17, 2022
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13 min read
FDA
Nexus Pharmaceuticals Inc. Receives FDA Approval of Erythromycin Lactobionate for Injection, USP
February 17, 2022
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1 min read
FDA
Lupin Announces FDA Approval of Supplemental New Drug Application for SOLOSEC® (secnidazole) in Adolescents for both the Treatment of Bacterial Vaginosis in Females and Trichomoniasis
February 17, 2022
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6 min read
FDA
EvoEndo Announces US FDA 510(k) Clearance for Single-Use Unsedated Transnasal Endoscopy (TNE) System
February 17, 2022
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4 min read
FDA
Kato Wins FDA Approval for Human Studies of Drug for Retinal Disorders
February 16, 2022
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3 min read
FDA
Accord Healthcare Inc. Announces Launch of First-to-Market Additional Strengths of Hydroxychloroquine Sulfate Tablets, in the U.S.
February 16, 2022
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2 min read
FDA
Tandem Diabetes Care Announces FDA Clearance for the t:slim X2 Insulin Pump to Bolus Using the t:connect Mobile App
February 16, 2022
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5 min read
FDA
LEXEO Therapeutics Announces FDA Clearance of Investigational New Drug Application for LX2006, an AAV-based Gene Therapy Candidate for Friedreich’s Ataxia Cardiomyopathy
February 16, 2022
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4 min read
FDA
FDA Grants Fast Track Designation to SBT101, the First Investigational AAV-Based Gene Therapy for Patients With Adrenomyeloneuropathy (AMN)
February 16, 2022
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3 min read
FDA
Rapid Medical Receives FDA Breakthrough Device Designation for Vasospasm Treatment
February 15, 2022
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3 min read
FDA
Cardiosense receives FDA Breakthrough Device designation for algorithm to identify patients at risk of decompensated heart failure
February 15, 2022
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4 min read
FDA
Neurocentria Obtains FDA Approval to Conduct Pivotal Phase IIb/III Clinical Trial for Testing Safety and Efficacy of Drug Candidate NRCT-101SR in Adults With ADHD
February 15, 2022
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5 min read
FDA
Foundation Medicine’s ctDNA Monitoring Assay, FoundationOne®Tracker, Granted Breakthrough Device Designation by U.S. Food and Drug Administration
February 15, 2022
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3 min read
FDA
Amring Pharmaceuticals Inc. Announces the Approval and Launch of Generic Lamotrigine Orally Disintegrating Tablets (ODT), USP
February 14, 2022
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3 min read
FDA
Axcella Therapeutics Announces FDA Fast Track Designation for AXA1125 in NASH
February 14, 2022
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5 min read
FDA
Avion Pharmaceuticals, LLC, an Alora Pharmaceuticals company, announces the FDA approval and availability of DHIVY™ for the treatment of Parkinson’s disease
February 14, 2022
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3 min read
FDA
ASCENSIA DIABETES CARE ANNOUNCES FDA APPROVAL OF THE EVERSENSE E3 CONTINUOUS GLUCOSE MONITORING SYSTEM FOR USE FOR UP TO 6 MONTHS
February 14, 2022
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2 min read
FDA
Motus GI Receives FDA Clearance to Market the Pure-Vu® EVS System
February 14, 2022
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5 min read
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