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Approvals

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FDA
FDA Approves Akili’s Therapeutic Video Game for ADHD
The game was reviewed through the agency’s de novo pathway and as a result, creates a new class of digital therapeutics.
June 16, 2020
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3 min read
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Mark Terry
FDA
Jazz Pharma Gets Approval for Zepzelca in the U.S. for Aggressive Lung Cancer
The approval was based on monotherapy clinical data from a trial in 105 adults with SCLC whose disease progressed after platinum-based chemotherapy.
June 16, 2020
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3 min read
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Mark Terry
IgorGolovniov/Shutterstock
FDA
FDA Cancels Emergency Use Authorization of Hydroxychloroquine for COVID-19
The FDA indicated that, based on new evidence, there was not enough supporting evidence for the two drugs to be considered effective in treating COVID-19.
June 15, 2020
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3 min read
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Mark Terry
FDA
ViiV’s Tivicay Approved for Children as Young as 4 Weeks with HIV
The U.S. Food and Drug Administration (FDA) approved ViiV Healthcare’s Tivicay PD (dolutegravir) in combination with other antiretroviral drugs for children with HIV.
June 15, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: June 15
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 15, 2020.
June 15, 2020
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3 min read
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BioSpace Editorial Staff
Uplizna got green signal from FDA
FDA
FDA Greenlight’s Viela Bio’s Uplizna for Rare Neuroinflammatory Autoimmune Disorder
The FDA approved Viela Bio’s Uplizna (inebilizumab-cdon) for adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-AQP4 antibody positive. About 80% of all NMOSD patients test positive for anti-AQP4 antibodies.
June 12, 2020
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3 min read
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Mark Terry
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
 · 
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
 · 
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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