Jiuyuan Gene’s Semaglutide Biosimilar Market Filing Accepted for Review in China
Hangzhou Jiuyuan Gene Engineering Co., Ltd., based in China, has announced that its market approval...
Drug
RemeGen Secures Fast-Track FDA Designation for Telitacicept in Sjögren’s Syndrome Treatment
China-based pharmaceutical company RemeGen (HKG: 9995) has announced that it has received fast-track designation (FTD)...
Hepalink Secures TFDA Approval for Enoxaparin Sodium Injection, Expanding Thrombosis Treatment Options in Thailand
Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399), based in China, has announced that it...
Junshi Biosciences Files for Approval of Ongericimab, Targeting Key Cholesterol Disorders
China’s Junshi Biosciences (HKG: 1877; SHA: 688180) has announced the submission of two market approval...
Zai Lab Announces Positive Phase III Data for Krazati in KRASG12C-mutated NSCLC, Plans NDA Filing in China
Zai Lab (NASDAQ: ZLAB; HKG: 9688), a China-based biotech company, has announced positive Phase III...
Alexion’s Voydeya Earns FDA Nod as Add-on Therapy for PNH-Associated Extravascular Hemolysis
Alexion, the rare disease unit of AstraZeneca (AZ; NASDAQ: AZN) based in the UK, has...
Viatris Launches Ryzumvi in the US for Rapid Reversal of Pharmacologically-Induced Pupil Dilation
Viatris Inc. (NASDAQ: VTRS) has launched its alpha-adrenergic blocker Ryzumvi (phentolamine) in the US market,...
J&J’s Nipocalimab Fast-Tracked by FDA for Reducing FNAIT Risk in Pregnant Adults
The US Food and Drug Administration (FDA) has accepted Johnson & Johnson’s (J&J; NYSE: JNJ)...
Shanghai Fosun Pharma and Meiji Seika Pharma Launch Phase III Studies for Anti-Infective Nacubactam
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based...
Junshi Biosciences Gets Green Light for Global Phase III Study of Tifcemalimab Combination Therapy in LS-SCLC
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877), a leading biotech company based in China, has...
FDA Reviews Eisai’s Monthly Maintenance Therapy for Early Alzheimer’s with Leqembi
Last week, the US Food and Drug Administration (FDA) announced the acceptance of an indication...
Bristol Myers Squibb’s Krazati Trial Yields Positive Phase III Results in NSCLC
Last week, Bristol Myers Squibb (BMS; NYSE: BMY) unveiled preliminary results from a Phase III...
China’s CNIPA Upholds Patent for Nobel-Winning CRISPR/Cas9 Gene Editing Technology
The China National Intellectual Property Administration (CNIPA) has upheld a key patent surrounding the CRISPR/Cas9...
AstraZeneca’s AKT Inhibitor Truqap Approved in Japan for HR+, HER2- Breast Cancer
AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, has registered with Japan’s Ministry of Health,...
Kobayashi Pharmaceutical Faces Expanding Scandal Over Contaminated Red Yeast Rice Supplements
Kobayashi Pharmaceutical, based in Japan, is facing a deepening scandal over contaminated red yeast rice...
Bristol Myers Squibb’s Zeposia Fails to Meet Primary Endpoint in Crohn’s Disease Trial
Bristol Myers Squibb (BMS; NYSE: BMY) has announced that a Phase III study for its...
Regenxbio Reports Stable Visual Acuity Improvements with AbbVie’s Gene Therapy in Wet AMD Trial
Regenxbio (NASDAQ: RGNX), the development partner for AbbVie’s (NYSE: ABBV) gene therapy ABBV-RGX-314, has announced...
Jiangsu Hengrui’s SHR-A1921 Earns FDA Fast-Track Status for Platinum-Resistant Ovarian Cancer Therapies
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a distinguished pharmaceutical entity, has announced that it...
Hengrui Pharmaceuticals Advances Clinical Trial for PD-L1 Inhibitor Combo in CLDN18.2 Positive Tumors
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company, has received approval from...
Allergan Aesthetics Launches SKINMEDICA in China, Targeting Booming Skincare Market
Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has announced the market launch of its...