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Approvals

Drug Development
Biopharma Update on the Novel Coronavirus: June 12
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 12, 2020.
June 11, 2020
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4 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: June 10
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 10, 2020.
June 10, 2020
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4 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: June 8
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 8, 2020.
June 8, 2020
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3 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: June 5
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 5, 2020.
June 5, 2020
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3 min read
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BioSpace Editorial Staff
lucarista / Shutterstock
FDA
New Roche Diagnostics Device Tests Levels of IL-6 in COVID-19 Patients
Instead of detecting the virus, this device can help determine who might be at risk for intubation and mechanical ventilation.
June 4, 2020
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2 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: June 4
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 4, 2020.
June 4, 2020
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4 min read
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BioSpace Editorial Staff
FDA
FDA Delays Ruling on Novartis’ Relapsing Multiple Sclerosis Drug Arzerra
On Tuesday, the FDA extended its review of the Supplemental Biologics License Application for Arzerra in this indication by three months.
June 3, 2020
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2 min read
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Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: June 3
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 3, 2020.
June 3, 2020
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4 min read
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BioSpace Editorial Staff
Oriahnn is the new non-surgical treatment for heav
FDA
FDA Approves New Treatment Oriahnn for Heavy Menstrual Bleeding Associated with Uterine Fibroids
AbbVie won first-of-its-kind approval for a non-surgical treatment, Oriahnn, aimed at treating heavy menstrual bleeding due to uterine fibroids, a common non-cancerous tumor, in pre-menopausal women.
June 1, 2020
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2 min read
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Alex Keown
FDA
Genentech’s Tecentriq-Avastin Combo Approved for HCC, an Improvement on Standard of Care
Tecentriq is an anti-PD-L1 checkpoint inhibitor. Avastin binds to the VEGF protein, which plays a significant role in the development and maintenance of blood vessels by cancer cells.
June 1, 2020
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3 min read
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Mark Terry
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PRESS RELEASES
FDA
Valencia Technologies Announces FDA Approval of eCoin® Therapy to Treat Urinary Urge Incontinence
March 2, 2022
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5 min read
FDA
Harpoon Therapeutics Receives FDA Fast Track Designation for HPN217
March 2, 2022
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5 min read
FDA
Pfizer Granted FDA Breakthrough Therapy Designation for Respiratory Syncytial Virus (RSV) Vaccine Candidate for the Prevention of RSV in Infants from Birth up to Six Months of Age by Active Immunization of Pregnant Women
March 2, 2022
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9 min read
FDA
Amneal Enters U.S. Biosimilars Market With Approval of RELEUKOTM (filgrastim-ayow)
March 1, 2022
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8 min read
FDA
CARVYKTI™ (ciltacabtagene autoleucel), BCMA-Directed CAR-T Therapy, Receives U.S. FDA Approval for the Treatment of Adult Patients With Relapsed or Refractory Multiple Myeloma
February 28, 2022
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25 min read
FDA
U.S. FDA Approves CARVYKTI™ (ciltacabtagene autoleucel), Janssen’s First Cell Therapy, a BCMA-Directed CAR-T Immunotherapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
February 28, 2022
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24 min read
FDA
CTI BioPharma Announces FDA Accelerated Approval of VONJO™ (pacritinib) for the Treatment of Adult Patients with Myelofibrosis and Thrombocytopenia
February 28, 2022
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13 min read
FDA
US FDA approves Jardiance® (empagliflozin) to treat adults with heart failure regardless of left ventricular ejection fraction
February 24, 2022
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16 min read
FDA
FDA Approves Treatment for Wider Range of Patients with Heart Failure
February 24, 2022
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3 min read
FDA
Viz.ai Receives FDA 510(k) Clearance for Viz ANEURYSM
February 24, 2022
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4 min read
FDA
FDA Approves Nalmefene HCl Injection, 2mg/2mL (1mg/1mL) for the Treatment of Known or Suspected Opioid Overdose with Natural or Synthetic Opioids
February 23, 2022
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5 min read
FDA
Teleflex Receives FDA Clearance for Expanded Indication for Specialty Catheter and Coronary Guidewire Use in CTO PCI Procedures
February 23, 2022
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4 min read
FDA
Medtronic receives FDA approval for InterStim X™ system, the next generation of the most personalized sacral nerve stimulation therapy for bladder and bowel control
February 22, 2022
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5 min read
FDA
Minimally Invasive Epilepsy Treatment EASEE Receives FDA Breakthrough Device Designation
February 22, 2022
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5 min read
FDA
Abbott’s CardioMEMS™ HF System Receives FDA Approval to Support Patients Battling Earlier-Stage Heart Failure
February 21, 2022
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5 min read
FDA
U.S. FDA Approves FoundationOne®CDx as a Companion Diagnostic for KEYTRUDA® (pembrolizumab) to Identify Patients with Microsatellite Instability-High (MSI-H) Solid Tumors
February 21, 2022
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4 min read
FDA
Medtronic receives FDA expanded approval for cardiac cryoablation catheters for pediatric treatment of a common heart rhythm condition
February 18, 2022
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7 min read
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
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