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...
Bayer Co.Lab Adds Arbele and Alphelix – China Innovation Cluster Reaches 12 Resident Biotech Startups
Bayer Co.Lab announced that Arbele Limited and Alphelix Bioscience have joined its co-creation platform, bringing...
FDA Approves GSK’s Wellcovorin for Cerebral Folate Deficiency – First Treatment for Rare FOLR1 Genetic Disorder
The U.S. Food and Drug Administration (FDA) approved expanded use of GlaxoSmithKline’s (GSK, NYSE: GSK)...
Astellas’ XOSPATA Fails Phase III Primary Endpoint in Frontline AML – FLT3 Inhibitor Misses OS Benefit vs. Midostaurin
Astellas Pharma Inc. (TYO: 4503) and the HOVON Foundation announced that the Phase III HOVON...
Keymed Biosciences Initiates CMG901 Phase III – AstraZeneca Triggers $45 Million Milestone for Claudin 18.2 ADC
Keymed Biosciences Inc. (HKG: 2162) announced the initiation of Phase III clinical trials for CMG901,...
SicaGene’s SG12 ASO Wins NMPA Approval – Antisense Oligonucleotide Targets Hepatitis B Functional Cure
SicaGene (Beijing) Biotechnology Co., LTD announced that SG12 injection, a self-developed antisense oligonucleotide (ASO), has...
Kelun-Biotech’s SKB575/HBM7575 Wins NMPA Approval – Long-Acting TSLP Bispecific Targets Atopic Dermatitis with Q3+ Dosing Potential
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) announced that SKB575/HBM7575, a long-acting bispecific antibody (bsAb)...
Henlius Biotech’s HLX3901 Wins NMPA Approval – First-in-Class Tetra-Specific Antibody Targets DLL3-Positive Solid Tumors
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that HLX3901, a first-in-class tetra-specific antibody targeting DLL3...
Qyuns Therapeutics’ QX002N NDA Accepted by NMPA – IL-17A Antibody Targets Ankylosing Spondylitis Market
Qyuns Therapeutics (HKG: 2509) announced that the New Drug Application (NDA) for QX002N, its first...
GSK Licenses Linerixibat to Alfasigma for $300 Million Upfront – IBAT Inhibitor Targets PBC Pruritus with $690 Million Total Deal Value
GlaxoSmithKline (GSK, NYSE: GSK) and Alfasigma S.p.A. announced a licensing agreement granting Alfasigma exclusive global rights...
FDA Streamlines Biosimilar Development – New Guidance Cuts PK Study Costs by 50%, Accelerates Path to Market
The U.S. Food and Drug Administration (FDA) announced a major policy shift to accelerate biosimilar...
Everest Medicines Launches Etrasimod in China – Next-Gen S1P Modulator Hits Market for Ulcerative Colitis
Everest Medicines (HKG: 1952) announced the formal commercial launch of Etrasimod, with the first prescription...
FDA Advances Section 804 Drug Importation Program – States Meet Agency on Canadian Prescription Import Pathway
The U.S. Food and Drug Administration (FDA) convened meetings with multiple states this week to...
Novo Nordisk Settles with Hims & Hers – Ozempic Wegovy Distribution Deal Ends Patent Litigation, Eliminates Compounded GLP-1 Advertising
Novo Nordisk A/S (NYSE: NVO) announced a settlement agreement with telehealth company Hims & Hers...
NMPA Removes OCALIVA from GQCE Reference List – Obeticholic Acid Stripped Over Safety Concerns, Benefit-Risk Profile
China’s National Medical Products Administration (NMPA) released the 102nd batch of reference drugs for generic...
HutchMed Withdraws TAZVERIK from China – Safety Concerns Drive Global Recall of Epizyme/Ipsen EZH2 Inhibitor
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced immediate withdrawal and product recall of TAZVERIK...
Fosun Pharma’s HLX316 Wins NMPA Approval – First-in-Class B7-H3 Sialidase Heterodimer Targets Advanced Solid Tumors
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that HLX316, a novel...