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Approvals

FDA
FDA Approves Sanofi’s Meningococcal Meningitis Vaccine
David Loew, head of Sanofi Pasteur, said U.S. approval of the vaccine is an important milestone in the fight against meningococcal meningitis, a serious global health challenge that can be fatal within 24 hours.
April 24, 2020
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2 min read
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Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: April 24
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 24, 2020.
April 24, 2020
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7 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 23
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 23, 2020.
April 23, 2020
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5 min read
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BioSpace Editorial Staff
Chronic lymphocytic leukemia
FDA
Imbruvica-Rituximab Combo Approved by FDA for Chronic Lymphocytic Leukemia
The FDA recently approved the combination of Imbruvica-Rituximab for treating chronic lymphocytic leukemia. Here’s everything you need to know.
April 22, 2020
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2 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 22
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 22, 2020.
April 22, 2020
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5 min read
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BioSpace Editorial Staff
FDA
LabCorp’s COVID-19 At-Home Test Kit Approved for Emergency Use
It does not require healthcare workers and first responders to conduct the test using personal protective equipment. Therefore, it should prevent the risk of transmitting the virus.
April 21, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 21
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 21, 2020.
April 21, 2020
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6 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: April 20
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 20, 2020.
April 20, 2020
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4 min read
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BioSpace Editorial Staff
FDA
FDA Approves Incyte’s Pemazyre for Rare Bile Duct Cancer
The U.S. Food and Drug Administration (FDA) approved Incyte’s Pemazyre (pemigatinib) for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.
April 20, 2020
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3 min read
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Mark Terry
TARPEYO is the first FDA-approved drug for immunog
FDA
Seattle Genetics’ Tukysa Earns FDA Approval for HER2+ Breast Cancer
Tukysa came out of Project Orbis, a multinational partnership between the FDA, the Australian Therapeutic Goods Administration, Health Canada, Health Sciences Authority and Swissmedic.
April 20, 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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