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Drug Approval

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

Japan Becomes First in the World to Approve Dupixent® for Chronic Spontaneous Urticaria (CSU)

Approval based primarily on results from Phase 3 trial showing Dupixent significantly reduced itch compared to placebo CSU is the fifth appr...

February 17, 2024 | News

AstraZeneca's TAGRISSO® (osimertinib) with Chemotherapy Approved in the US for EGFR-Mutated Advanced Lung Cancer

AstraZeneca’s TAGRISSO® (osimertinib) with the addition of chemotherapy has been approved in the US for the treatment of adult patients with...

February 17, 2024 | News

FDA Prioritizes Review of Bristol Myers Squibb's Augtyro™ for NTRK-Positive Solid Tumors

Bristol Myers Squibb (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for A...

February 15, 2024 | News

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