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Approvals

FDA
FDA Action Alert: Sanofi, Neurocrine, Correvio and United
Here’s a look at what’s on the U.S. Food and Drug Administration’s schedule for the next two weeks.
April 17, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: April 17
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 17, 2020.
April 17, 2020
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6 min read
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BioSpace Editorial Staff
FDA
FDA Gives UroGen’s Jelmyto Expedited Approval for Urothelial Cancer
Jelmyto is the first and only non-surgical treatment for patients with this indication. Here’s everything you need to know about it.
April 16, 2020
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2 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 16
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 16, 2020.
April 16, 2020
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8 min read
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BioSpace Editorial Staff
FDA
FDA Approves Use of Ortho’s High-Throughput, Automated COVID-19 Antibody Test
Antibody tests, also called serological tests, test if the individual has been exposed to SARS-CoV-2, the novel coronavirus that causes COVID-19.
April 15, 2020
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2 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: April 15
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 15, 2020.
April 15, 2020
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7 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 14
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 14, 2020.
April 14, 2020
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6 min read
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BioSpace Editorial Staff
FDA
FDA Approves Rutgers’ Saliva Test for COVID-19
The U.S. Food and Drug Administration granted emergency use authorization to Rutgers’ RUCDR Infinite Biologics for its test that uses saliva.
April 13, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 13
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 13, 2020.
April 13, 2020
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4 min read
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BioSpace Editorial Staff
Stanford serology test is finally here.
FDA
Stanford Serology Test: Stanford Joins List of Organizations Offering COVID-19 Antibody Testing
The Stanford serology test provides results in two to three days and Stanford Health Care can test 500 samples per day. Know what more it has to offer.
April 13, 2020
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3 min read
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Mark Terry
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PRESS RELEASES
Press Releases
Plus Therapeutics Announces Read Out of Type B Meeting with the FDA with Goal of Accelerating Approval of REYOBIQ™ for Leptomeningeal Metastases
January 8, 2026
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7 min read
Press Releases
Saluda Medical Receives Regulatory Approval for EVA™ Sensing Technology in Europe with recognition in Australia
January 8, 2026
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4 min read
Press Releases
FDA Approves New 2-Gram Presentation of Fibryga®, Enhancing Convenience and Precision in Treating Acquired Fibrinogen Deficiency
January 8, 2026
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4 min read
Press Releases
Arrowhead Pharmaceuticals Announces NMPA Approval of REDEMPLO® (plozasiran) for Familial Chylomicronemia Syndrome (FCS) in China
January 7, 2026
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7 min read
Press Releases
Milestone Pharmaceuticals Announces Acceptance of Marketing Authorization Application for Etripamil Nasal Spray in PSVT by the European Medicines Agency
January 6, 2026
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7 min read
Press Releases
Stereotaxis Receives FDA Approval for MAGiC Ablation Catheter
January 6, 2026
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4 min read
Press Releases
Zai Lab Announces National Medical Products Administration (NMPA) Approval of AUGTYRO™ (repotrectinib) for Patients with NTRK-Positive Solid Tumors
January 6, 2026
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5 min read
Press Releases
MAVIRET® receives Health Canada Approval for the Treatment of Acute Hepatitis C Virus
January 6, 2026
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6 min read
Press Releases
Alpha Tau Submits First Pre-Market Approval Module to the FDA for Alpha DaRT® for the Treatment of Recurrent Cutaneous Squamous Cell Carcinoma (cSCC)
January 5, 2026
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5 min read
Press Releases
Dechra Announces FDA Approval of Zygolide® (pergolide tablets) for the Control of Clinical Signs Associated with Pituitary Pars Intermedia Dysfunction (Equine Cushing’s Disease) in Horses
January 5, 2026
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3 min read
Press Releases
Arrowhead Pharmaceuticals Announces Health Canada Approval of REDEMPLO™ (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS)
January 5, 2026
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10 min read
Press Releases
Kelun-Biotech Receives Investigational New Drug Approval for ITGB6-Targeted ADC SKB105 from the NMPA
January 5, 2026
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3 min read
Press Releases
Vanda Pharmaceuticals Announces FDA Approval of NEREUS™ (tradipitant) for the Prevention of Vomiting Induced by Motion: A Historic Scientific Milestone in the Prevention of Motion Sickness
December 30, 2025
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9 min read
Press Releases
Establishment Labs Submits to FDA for Approval of Motiva Implants in Breast Reconstruction
December 29, 2025
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7 min read
Press Releases
China’s First Domestic Anti-CTLA-4 Monoclonal Antibody, Innovent’s TABOSUN® (Ipilimumab N01 Injection) Received NMPA Approval
December 25, 2025
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11 min read
Press Releases
FDA Approves Omeros’ YARTEMLEA® – First and Only Therapy Indicated for TA-TMA
December 25, 2025
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17 min read
Press Releases
U.S. FDA Approves Agios’ AQVESME™ (mitapivat) for the Treatment of Anemia in Adults with Alpha- or Beta-Thalassemia
December 24, 2025
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15 min read
Press Releases
FDA Approves Edwards Lifesciences’ SAPIEN M3 Mitral Valve Replacement System as First Transseptal Transcatheter Therapy
December 24, 2025
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4 min read
Press Releases
Zai Lab Announces Approval of COBENFY (xanomeline and trospium chloride) in China, a First-in-Class Therapy for Schizophrenia
December 24, 2025
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7 min read
Press Releases
Press Release: Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia
December 24, 2025
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9 min read
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