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Approvals

Maxigesic IV on hold until FDA gets clarity on the
FDA
FDA Approves Trevena’s IV Opioid Olinvyk for Short-Term Acute Pain Management
Olinvyk is indicated for short-term intravenous use in hospitals or other controlled clinical settings, such as during inpatient and outpatient procedures.
August 13, 2020
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2 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: August 12
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 12, 2020.
August 11, 2020
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5 min read
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BioSpace Editorial Staff
FDA
Genentech Joins Biogen and Novartis in the Spinal Muscular Atrophy Market
Genentech, a Roche company, announced the U.S. Food and Drug Administration (FDA) had approved its Evrysdi (risdiplam) for spinal muscular atrophy (SMA) in adults and children two months of age and older.
August 10, 2020
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4 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: August 7
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 7, 2020.
August 6, 2020
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3 min read
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BioSpace Editorial Staff
FDA
FDA Approves GSK’s Blenrep as Fourth-Line Multiple Myeloma Monotherapy Treatment
Blenrep is GSK’s second regulatory approval in four months. GlaxoSmithKline is once again making its mark as an oncology-focused pharmaceutical company.
August 6, 2020
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3 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: August 5
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 5, 2020.
August 4, 2020
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5 min read
 · 
BioSpace Editorial Staff
Gavreto is approved by FDA yet again.
FDA
FDA Approves MorphoSys and Incyte’s DLBCL Drug Monjuvi
Eight months after inking a collaboration deal, MorphoSys and Incyte won approval for Monjuvi for adult patients with relapsed or refractory diffuse large B-cell lymphoma.
August 3, 2020
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2 min read
 · 
Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: August 3
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 3, 2020.
August 3, 2020
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3 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 31
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 31, 2020.
July 30, 2020
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4 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 29
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 29, 2020.
July 29, 2020
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5 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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