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...
Drug
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...
CMS Launches Opzelura Nationwide – First Topical JAK Inhibitor for Vitiligo Reaches 1,300+ Pharmacies Across 30 Chinese Provinces
China Medical System Holdings (CMS; HKG: 0867) announced that first prescriptions of Ruxolitinib Phosphate Cream...
Essight Bio’s ES502 Wins FDA Phase I Approval – First TCR×CD3 Bispecific Targeting RAS G12V Mutations Enters Clinic
Shanghai Essight Biotechnology Co., Ltd. announced that ES502 Injection has received FDA approval to proceed...
Changchun GeneScience’s GenSci128 Wins FDA Orphan Drug Designation – TP53 Y220C Reactivator Targets Pancreatic Cancer
Changchun GeneScience Pharmaceutical Inc. announced that GenSci128 tablets, its independently developed selective TP53 Y220C mutation...
Sino Biopharm’s TQB3205 Wins NMPA Approval – First China-Developed Pan-KRAS Inhibitor Enters Clinic for Advanced Cancers
Sino Biopharmaceutical Limited (HKG: 1177) announced that TQB3205, an orally administered Pan-KRAS inhibitor independently developed...
Huadong Medicine’s HDM2017 Wins FDA Orphan Drug Designation – CDH17 ADC Targets Three Gastrointestinal Cancers
Huadong Medicine Co., Ltd (SHE: 000963) announced that HDM2017, its independently developed CDH17-targeting antibody-drug conjugate...
Hengrui’s SHR-2524 Wins NMPA Phase I Approval – Novel Subcutaneous Formulation Plus Bevacizumab Targets First-Line Liver Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced NMPA clearance to initiate a...
Boehringer Ingelheim’s Jascayd (Nerandomilast) Launches in Shanghai – First PDE4B Inhibitor for Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim announced the first prescription issuance for Jascayd (nerandomilast tablets) in Shanghai, marking the...
Huadong Medicine’s HDM2024 Wins FDA Phase I Approval – First-in-Class EGFR/HER3 Bispecific ADC Targets Advanced Solid Tumors
Huadong Medicine Co., Ltd (SHE: 000963) announced that HDM2024, a Category 1 innovative bispecific antibody-drug...
J&J’s AKEEGA Wins EU Approval for mHSPC – PARP/Abiraterone Combo Expands to Earlier-Line Prostate Cancer
Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission (EC) has approved a...
Abbisko’s ABSK061 Wins FDA Rare Pediatric Disease Designation – FGFR2/3 Inhibitor Targets Achondroplasia
Abbisko Therapeutics Co., Ltd (HKG: 2256) announced that ABSK061, its self-developed highly selective small-molecule FGFR2/3...
Zelgen’s Zesuning Launches Nationwide – First China-Approved Recombinant TSH for Thyroid Cancer Follow-Up
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced the nationwide commercial launch of Zesuning (injectable...
Fosun Pharma’s Tenapanor (Vteglea) Issues First China Prescription – NHE3 Inhibitor Targets Hyperphosphatemia in Dialysis Patients
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced the first prescription issuance...
Pfizer’s Tilrekimig Hits Phase 2 Primary Endpoint – IL-4/IL-13/TSLP Trispecific Shows 52% EASI-75 Response in Atopic Dermatitis
Pfizer Inc. (NYSE: PFE) announced positive topline results from a Phase 2 study of tilrekimig...
FDA Accepts ENHERTU sBLA with Priority Review – HER2 ADC Seeks Early Breast Cancer Approval with 53% Recurrence Risk Reduction
AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced that the U.S. FDA has...
J&J Files TECVAYLI Line Extension with EMA – BCMA Bispecific Seeks Earlier Use in Second-Line Multiple Myeloma
Johnson & Johnson (J&J, NYSE: JNJ) announced the submission of a Type II variation application...
HighTide Therapeutics’ HTD1801 NDA Accepted by NMPA – First-in-Class AMPK/NLRP3 Dual-Target Drug for Type 2 Diabetes
HighTide Therapeutics Inc. (HKG: 2511) announced that China’s National Medical Products Administration (NMPA) has accepted...
AstraZeneca Initiates CLARITY-Gastric 02 Phase III – Sonesitatug Vedotin Combo Triggers $45 Million Milestone from KYM Biosciences
AstraZeneca (AZ, NASDAQ: AZN) announced the initiation of CLARITY-Gastric 02, a multi-center, randomized, controlled Phase...