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Approvals

Drug Development
Biopharma Update on the Novel Coronavirus: June 26
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 26, 2020.
June 25, 2020
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3 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: June 24
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 24, 2020.
June 23, 2020
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4 min read
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BioSpace Editorial Staff
FDA
Karyopharm’s Xpovio Wins Second FDA Approval for DLBCL Treatment
The U.S. Food and Drug Administration greenlit Karyopharm Therapeutics’ Xpovio (selinexor) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) under accelerated approval.
June 23, 2020
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2 min read
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Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: June 22
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 22, 2020.
June 22, 2020
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3 min read
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BioSpace Editorial Staff
FDA
FDA Approves Bone-Softening Disorder Treatment Crysvita
Crysvita is a drug developed by Ultragenyx Pharmaceutical and Tokyo-based Kyowa Kirin Co. Ltd., a specialty pharmaceutical company.
June 19, 2020
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2 min read
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Alex Keown
FDA has finally approved tavneos for ANCA Vasculit
FDA
Epizyme’s Tazverik Picks Up Its Second FDA Approval of 2020
The FDA approved a supplemental New Drug Application for Tazverik (tazemetostat) for the treatment of two distinct follicular lymphoma (FL) indications.
June 19, 2020
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2 min read
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Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: June 19
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 19, 2020.
June 18, 2020
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4 min read
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BioSpace Editorial Staff
FDA
FDA Approves Second Biomarker-Specific Indication for Merck’s Keytruda
This is the second such biomarker-specific approval for Keytruda. The first biomarker-specific approval came in 2017.
June 17, 2020
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2 min read
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Alex Keown
Uplizna got green signal from FDA
FDA
FDA Greenlights Two Novartis Drugs, Including First for Adult-Onset Still’s Disease
Novartis is the first company to the finish line with an approved treatment for Adult-Onset Still’s Disease (AOSD), a rare autoinflammatory disease of unknown origin.
June 17, 2020
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2 min read
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Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: June 17
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 17, 2020.
June 16, 2020
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5 min read
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BioSpace Editorial Staff
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PRESS RELEASES
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
Press Releases
Health Canada Approves TEVIMBRA® (tislelizumab for injection) in Combination with Gemcitabine and Cisplatin for the First-Line Treatment of Adult Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma
December 24, 2025
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10 min read
Press Releases
InnoCare Announces NMPA Approval of a Phase II Clinical Trial of TYK2 Inhibitor ICP-488 for Cutaneous Lupus Erythematosus
December 23, 2025
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1 min read
Press Releases
IRLAB Receives Approval for a Phase Ib Study with IRL757 in Parkinson’s Disease
December 23, 2025
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4 min read
Press Releases
Dupixent® (dupilumab) Approved in Japan for Children Aged 6 to 11 Years with Bronchial Asthma
December 23, 2025
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23 min read
Press Releases
Press Release: Sanofi and Regeneron’s Dupixent approved in Japan for children aged 6 to 11 years with bronchial asthma
December 23, 2025
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14 min read
Press Releases
GC Biopharma Secures IND Approval for Phase 1 Clinical Trial of COVID-19 mRNA Vaccine in Korea
December 23, 2025
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3 min read
Press Releases
Samsung Bioepis Announces Approval of Ustekinumab Biosimilar in Japan
December 23, 2025
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2 min read
Press Releases
FDA approves Novo Nordisk’s Wegovy® pill, the first and only oral GLP-1 for weight loss in adults
December 23, 2025
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14 min read
Press Releases
Novo Nordisk A/S: Wegovy® pill approved in the US as first oral GLP-1 for weight management
December 23, 2025
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4 min read
Press Releases
Amneal Announces FDA Approval of Denosumab Biosimilars Referencing Prolia® and XGEVA®
December 23, 2025
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6 min read
Press Releases
RevBio® Receives Approval from FDA to Start a Dental Clinical Trial for its Regenerative Bone Glue
December 23, 2025
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3 min read
Press Releases
Abbott’s Volt™ Pulsed Field Ablation System Receives FDA Approval to Treat Patients with Atrial Fibrillation
December 23, 2025
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5 min read
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