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Approvals

Policy
Biopharma Update on the Novel Coronavirus: August 26
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 26, 2020.
August 25, 2020
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4 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: August 24
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 24, 2020.
August 24, 2020
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2 min read
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BioSpace Editorial Staff
FDA
FDA Greenlights Novartis’ Kesimpta for Multiple Sclerosis
The U.S. Food and Drug Administration (FDA) approved Novartis’ Kesimpta (ofatumumab) for relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
August 21, 2020
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2 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: August 21
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 21, 2020.
August 20, 2020
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5 min read
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BioSpace Editorial Staff
FDA
Mylan Wins Approval for First Generic to Biogen’s MS Drug Tecfidera
This morning, Mylan announced the launch of its new generic offering, dimethyl fumarate delayed-release capsules for the treatment of relapsing forms of multiple sclerosis.
August 19, 2020
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2 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: August 19
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 19, 2020.
August 17, 2020
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2 min read
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BioSpace Editorial Staff
FDA
FDA Approves Genentech’s Enspryng for Neuromyelitis Optica Spectrum Disorder
The U.S. Food and Drug Administration approved Genentech’s Enspryng (satralizumab-mwge) as a subcutaneous treatment for adults with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder.
August 17, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: August 17
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 17, 2020.
August 17, 2020
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2 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: August 14
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 14, 2020.
August 13, 2020
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3 min read
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BioSpace Editorial Staff
Duchenne Muscular Dystrophy
FDA
FDA Approves NS Pharma’s Viltepso for Duchenne Muscular Dystrophy
The U.S. Food and Drug Administration (FDA) approved another therapy for Duchenne muscular dystrophy (DMD), this time NS Pharma’s Viltepso (viltolarsen).
August 13, 2020
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3 min read
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Mark Terry
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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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