BioPharma Drug Approval
FDA Grants Nefecon® Orphan Drug Exclusivity for Seven Years
Everest Medicines licensing partner Calliditas Therapeutics AB announced that the U.S. FDA has granted an orphan drug exclusivity period of seven yea...
March 12, 2024 | News
Macau Poised to Be First in Asia to Approve Everest's Etrasimod for Ulcerative Colitis
Macau is on course to become the first of Everest's Asian territories to get etrasimod approval -- Can provide access to patients in China's&nbs...
March 11, 2024 | News
TransThera Launches Global Phase 3 Trial for Cholangiocarcinoma in EU, Receives Orphan Drug Status for Tinengotinib from EMA
TransThera, a clinical-stage biopharmaceutical company dedicated to innovating differentiated drugs globally, today announced that the randomized, controll...
March 11, 2024 | News
VISEN Pharmaceuticals' Groundbreaking Growth Hormone Therapy BLA Accepted by China NMPA
VISEN Pharmaceuticals (VISEN), an innovative biopharmaceutical company focused on endocrine diseases, announced that the Biologics License Application (BLA...
March 08, 2024 | News
Epitomee® Submits Innovative Weight Loss Capsule for FDA Clearance
The Epitomee® capsule is designed for oral use and stands out as a drug-free option, clinically validated to be both effective and safe for adu...
March 07, 2024 | News
Innovent Biologics and AnHeart Therapeutics Secure Second NDA Acceptance for Groundbreaking Lung Cancer Treatment in China
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality me...
March 06, 2024 | News
Caliway's CBL-514 Gains FDA Orphan Drug and Fast Track Designations for Dercum's Disease Treatment
Caliway Biopharmaceuticals (Caliway) announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to CBL-514 for Dercum...
March 05, 2024 | News
Teva Partners with Jiangsu Nhwa to Enhance AUSTEDO® Access in China
“Nhwa has deep neuro-psychiatry expertise and capabilities, from research and development to commercialization,” commented Theodor Wee,...
February 28, 2024 | News
Everest Medicines, Kezar Get China NMPA Nod for Lupus Nephritis Trial
Everest Medicines (HKEX 1952.HK) and Kezar Life Sciences, Inc. (Nasdaq: KZR) announced that the Center for Drug Evaluation (CDE) of China's Natio...
February 27, 2024 | News
European Commission Grants Approval to VELSIPITY®, a Landmark Oral Therapy for Ulcerative Colitis
Everest Medicines, in collaboration with Pfizer Inc., announced a significant development for patients with ulcerative colitis in the European Union. The E...
February 15, 2024 | News
Japan Accelerates Approval Process for Groundbreaking Urothelial Cancer Treatment by Astellas
Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") announced that Japan's Ministry of Health, Labour a...
February 19, 2024 | News
AffaMed's NDA for DEXTENZA Accepted by Singapore HSA for Post-Surgery Ocular Treatment
AffaMed Therapeutics ("AffaMed"), a biotechnology company dedicated to developing and commercializing transformative pharmaceutical, and surgical products&...
February 19, 2024 | News
Synbio Tech's Probiotic TWK10 Earns Taiwan FDA Approval for Anti-fatigue Health Claim
Synbio Tech is thrilled to announce that its groundbreaking probiotic strain, Lactiplantibacillus plantarum TWK10, has been awarded a prestigious...
February 19, 2024 | News
Jacobio Gains China CDE Approval for Phase III SHP2 and KRAS G12C Inhibitor Trial
This approved study in China is a randomized active controlled phase III trial design to evaluate the efficacy and safety of JAB-3312 in combinat...
February 19, 2024 | News
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