UniXell Bio Secures FDA Approval for UX‑GIP001 – First iPSC Allogeneic Cell Therapy for Epilepsy Enters US Clinical Trials
Shanghai UniXell Biotechnology Co., Ltd. announced that its iPSC‑derived allogeneic cell therapy UX‑GIP001 has received...
Drug
Eli Lilly Rolls Out USD 299 Zepbound KwikPen via LillyDirect – Self‑Pay Pricing for Dual‑Target Obesity Drug
Eli Lilly and Company (NYSE: LLY) announced that patients can now access the single‑patient‑use Zepbound...
Henlius Wins NMPA Approval for HLX07 Combination Trial – Anti-EGFR Biologic Plus Serplulimab Targets Squamous NSCLC
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that subsidiary Shanghai Henlius...
CSPC Pharma Secures Dual NMPA‑FDA Approval for PDE4B Inhaler SYH2059 – First‑in‑Class ILD Candidate Enters Global Clinical Development
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that its highly selective PDE4B inhibitor SYH2059 powder...
Alphamab Oncology Doses First Patient in JSKN027 Phase I Trial – First‑in‑Class PD‑L1/VEGFR2 Bispecific ADC Enters Clinic
Alphamab Oncology (HKG: 9966) has successfully dosed the first patient in the Phase I clinical...
Ascentage Pharma and Haisco Secure CDE SPARK Inclusion for Pediatric Oncology Candidates – APG‑115 and HSK42360 Target High‑Unmet‑Need Childhood Cancers
China’s Center for Drug Evaluation (CDE) has selected two innovative oncology assets for its Support...
Sino Biopharm’s TRD221 Wins NMPA Approval – Novel Polysaccharide Drug Targets Osteoarthritis via Complement Inhibition
Sino Biopharmaceutical Limited (HKG: 1177) announced that TRD221, a Category 1 innovative polysaccharide drug co-developed...
CMS Secures NMPA Approval for Desidustat – First Domestic HIF-PHI for Non-Dialysis CKD Anemia Enters China Market
China Medical System Holdings (CMS; HKG: 0867) announced marketing approval from China’s National Medical Products...
Hengrui’s Irinotecan Liposome (II) Wins NMPA Phase II Approval – Adjuvant Pancreatic Cancer Study vs. Gemcitabine/Capecitabine
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced NMPA clearance to initiate a...
3SBio Wins NMPA Approval for Eltrombopag Generic – TPO-RA Copycat Targets Novartis’ Revolade in China ITP/SAA Market
3SBio Inc. (HKG: 1530) announced NMPA marketing approval for its generic version of Novartis’ Revolade...
Chipscreen Biosciences’ CS08399 Wins NMPA Approval – PRMT5-MTA Inhibitor Targets MTAP-Deficient Solid Tumors and Lymphomas
Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced NMPA clearance to initiate a clinical study...
Novartis’ Cosentyx Wins FDA Pediatric Approval – Only IL-17A Inhibitor for Hidradenitis Suppurativa in Adolescents 12+
Novartis (NYSE: NVS) announced that Cosentyx (secukinumab) received U.S. FDA approval for treating pediatric patients aged...
Cutia Therapeutics’ CU-40105 Wins NMPA Approval – Topical Dutasteride Targets Androgenetic Alopecia with Reduced Systemic Exposure
Cutia Therapeutics announced NMPA clearance to initiate a clinical study for CU-40105, a topical dutasteride...
J&J’s Erda-iDRS Shows 89% Complete Response in NMIBC – Intravesical Erdafitinib System Advances to Phase II/III
Johnson & Johnson (J&J, NYSE: JNJ) announced positive Phase I results for Erda-iDRS, an investigational...
BeBetter Medicine’s Ifupinostat Wins NMPA Approval for PTCL Trial – First HDAC/PI3Kα Dual Inhibitor Enters First-Line Lymphoma Study
Guangzhou BeBetter Medicine Technology Co., Ltd (SHA: 688759) announced NMPA clearance to initiate a clinical...
Abbisko’s Irpagratinib Doses First Patient in Phase II HCC Trial – FGFR4 Inhibitor Plus Toripalimab/Bevacizumab Targets First-Line Liver Cancer
Abbisko Therapeutics Co., Ltd (HKG: 2256) announced first patient dosing in a Phase II clinical...
YolTech’s YOLT-202 Wins FDA Phase II/III Approval – In Vivo Base Editing Gene Therapy Targets Alpha-1 Antitrypsin Deficiency
YolTech Therapeutics announced FDA clearance to initiate an open-label, single-dose expansion Phase II/III clinical study...
GSK’s Arexvy Wins FDA Label Expansion – RSV Vaccine Now Covers High-Risk Adults Aged 18-49
GlaxoSmithKline (GSK, NYSE: GSK) announced FDA approval for a label expansion of its adjuvanted respiratory...
Biogen’s Salanersen Shows 75% NfL Reduction in SMA Phase Ib – Once-Yearly ASO Advances to Phase III
Biogen Inc. (NASDAQ: BIIB) presented supplemental Phase Ib data for salanersen, its investigational antisense oligonucleotide...
Sino Biopharm’s TQB3454 Hits Phase III Endpoints in IDH1+ Biliary Tract Cancer – China’s First IDH1 Inhibitor Poised for NDA Filing
Sino Biopharmaceutical (HKG: 1177) announced that TQB3454 Tablets, a Category 1 innovative drug developed by...