BioPharma Drug Approval
Gilead and Kite Oncology Announce Approval of Yescarta® for Early Treatment of DLBCL in Singapore
**-- In ZUMA-7, Yescarta Patients with DLBCL were 2.5 Times More Likely than SOC to be Alive at Two Years Without Cancer Progression or Nee...
June 10, 2024 | News
Genetic Signatures Receives FDA Clearance for EasyScreen™ Gastrointestinal Parasite Detection Kit
Genetic Signatures Limited a global molecular diagnostics company announces that the US Food & Drug Administration ("FDA") has cleared the Compan...
June 05, 2024 | News
Telix Pharmaceuticals Completes BLA Submission to FDA for Breakthrough Kidney Cancer Imaging Agent TLX250-CDx
Telix Pharmaceuticals announces that it has completed the submission of a Biologics License Application (BLA) to the United States (U.S.) Food an...
June 03, 2024 | News
Kexing Biopharm’s Subsidiary Receives Approval for Clinical Trials of Innovative GB08 Growth Hormone
Kexing Biopharm announced that Shenzhen Kexing Pharmaceutical Co., Ltd., its wholly-owned subsidiary, recently received a Notice of Approval for Drug Clini...
May 31, 2024 | News
FDA Approves Bkemv as First Interchangeable Biosimilar to Soliris
U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare di...
May 29, 2024 | News
Ractigen Therapeutics' saRNA Drug RAG-01 Receives Fast Track Designation from FDA
Ractigen Therapeutics, a pioneering developer of small activating RNA (saRNA) therapeutics, proudly announces that its flagship program, RAG-01, has been g...
May 22, 2024 | News
Ractigen Therapeutics Receives IND Approval for Phase 1 ALS Clinical Trials in China
Ractigen Therapeutics, a clinical-stage pharmaceutical company committed to developing pioneering therapies, announces that the Center for Drug ...
May 16, 2024 | News
EFECON® Becomes First Approved Therapy for IgAN in China, Offering Hope to Millions with Improved Patient Care and Disease Management
Everest Medicines, a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative medicines ...
May 15, 2024 | News
Eisai's Antiepileptic Drug Fycompa® Gains Approval in China for Additional Indication
Eisai Co., Ltd. announced that it has received approval in China for the additional indication of its in-house discovered antiepileptic drug (AED) Fycompa&...
May 14, 2024 | News
Mabwell Advances Clinical Study of Nectin-4-Targeting ADC for Triple-Negative Breast Cancer
Mabwell, an innovation-driven biopharmaceutical company with entire industry chain, announced the progress of the clinical study of its novel Nectin-4-targ...
May 14, 2024 | News
Brii Biosciences Secures Breakthrough Therapy Designations for Two HBV Treatments from NMPA
Brii Biosciences Limited a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet need,...
May 14, 2024 | News
SN Bioscience’s SNB-101 Receives FDA Fast Track Designation for Breakthrough Small Cell Lung Cancer Treatment
SN Bioscience Co. Ltd. (CEO Park Young-hwan) announced on May 7 that the FDA has granted Fast Track Designation for small cell lung cancer (...
May 13, 2024 | News
FDA Approves Geneoscopy's Noninvasive Colorectal Cancer Test, ColoSense
Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, announced that the U...
May 07, 2024 | News
Chipscreen's Chidamide Receives NMPA Approval for First-Line Treatment of DLBCL with MYC/BCL2 Expression
Shenzhen Chipscreen Biosciences announced that the company's lead innovative product Chidamide (Epidaza®) , an oral subtype-selective histone deacetyla...
May 01, 2024 | News
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