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BioPharma Drug Approval

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

Innovent Biologics Advances Novel Weight Management Drug Mazdutide with NDA Acceptance in China

This groundbreaking achievement marks mazdutide as the first GLP-1R/GCGR dual agonist to successfully complete Phase 3 trials in support of an NDA ...

February 08, 2024 | Regulatory

Luye Pharma Licenses Rivastigmine Patch to Myung In Pharm for South Korea Commercialization

The agreement for the collaboration was signed at a ceremony attended by executives from both sides. Dianbo Liu, Chairman of the Board of Directors of Luye...

February 06, 2024 | News

Acepodia Gains FDA Clearance for ACE2016, Initiates Phase 1 Study on Solid Tumor Treatment

This clearance marks a significant milestone for Acepodia, allowing the initiation of a Phase 1, first-in-human clinical trial to assess th...

February 05, 2024 | News

Biosyngen's BST02 Granted FDA Fast Track for Liver Cancer Treatment

Fast track is a process designed to facilitate development, and accelerate the review of drugs to treat serious or life-threatening conditions and fill an ...

February 02, 2024 | News

Vertex's Breakthrough VX-548: Transforming Pain Management with Rapid Relief and Safety, A New Era in Acute Pain Solutions

Treatment with VX-548 led to statistically significant improvement in pain compared to placebo as well as a clinically meaningful reduction in pain from ...

January 31, 2024 | News

CellVax Therapeutics Receives FDA Clearance for FK-PC101 Cancer Immunotherapy IND

FK-PC101 is CellVax's novel personalized cancer immunotherapy intended to treat prostate cancer patients who have a high risk of recurrence after prostatec...

January 30, 2024 | News

Oricell's OriCAR-017 CAR-T Therapy IND Cleared by FDA for Relapsed/Refractory Multiple Myeloma

OriCAR-017 is a chimeric antigen receptor (CAR) T cell therapy targeting GPRC5D. The therapy leverages Oricell's proprietary platforms including Ori®Ab...

January 30, 2024 | News

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