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Trials & Approvals FDA ApprovalGene Therapy
Krystal Biotech’s First Topical Gene Therapy Approved by FDA
2023-06-06
Trials & Approvals Astellas PharmaFezolinetant
FDA Approves Astellas’ Non-hormonal Menopause Treatment After Extended Review
2023-05-19
Trials & Approvals Gilead Sciences
Gilead’s HDV Drug Headed Towards European Approval Even With FDA Rejection
2023-05-08
Trials & Approvals GSKRSV vaccines
GSK Wins Approval For World’s First RSV Vaccine
2023-05-08
Trials & Approvals FDA
Ascendis’ Hormone Drug Hits Another FDA Roadblock on Path to Approval
2023-05-02
Trials & Approvals Pneumococcal VaccineFDA Approval
Pfizer Racks Up Infant Indication for Pneumococcal Vaccine
2023-05-01
Trials & Approvals Fecal Microbiota TransplantationFDA Approval
Nestle and Seres Land First-Ever Fecal Microbiota Product Approval From FDA
2023-04-27
Trials & Approvals BiogenAmyotrophic Lateral Sclerosis
FDA Grants Biogen’s Ultra-Rare ALS Med Accelerated Approval
2023-04-26
Regulatory India
Sun Pharma Temporarily Pauses Shipments from Mohali Following FDA’s Mandate for Corrective Actions
2023-04-24
Trials & Approvals RocheDLBCLPolivy
Roche Could Set New DLBCL Treatment Standard with First-Line Polivy Indication
2023-04-19
Trials & Approvals Allogeneic Cell TherapyFDA Approval
Gamida’s Allogeneic Cell Therapy Snags FDA Approval for Blood Cancers
2023-04-18
Trials & Approvals ModernaCancer Vaccine
Moderna’s Cancer Vaccine to Enter Phase 3 Trials This Year
2023-04-17
Trials & Approvals ModernamRNA Vaccine
Moderna’s mRNA Flu Vaccine Development Slow Going as Data Rolls In
2023-04-11
Trials & Approvals KeytrudaLenvima
Merck, Eisai’s Keytruda-Lenvima Combo Fails in Melanoma and Colorectal Cancer Trials
2023-04-10
Trials & Approvals Overdose
Emergent BioSolutions’ Over-The-Counter Naloxone Nasal Spray Receives FDA Greenlight
2023-03-30
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