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...
Hengrui’s HRS9531 Wins NMPA Approval for CKD Trial – Dual GIPR/GLP-1R Agonist Expands Beyond Diabetes and Obesity
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that HRS9531, a novel dual...
Merck KGaA Cuts SpringWorks Hippo Inhibitor and Hengrui PARP1 Program – R&D Pipeline Optimization Ditches €3.7 Billion in Acquired Assets
Merck KGaA (ETR: MRK) announced completion of a new R&D pipeline optimization, terminating development of...
Bristol-Myers Squibb’s Sotyktu Wins FDA Label Extension – TYK2 Inhibitor Expands to Psoriatic Arthritis
Bristol-Myers Squibb (BMS, NYSE: BMY) announced FDA approval for a label extension of Sotyktu (deucravacitinib),...
Servier to Acquire Day One Biopharmaceuticals for $2.5 Billion – French Pharma Expands U.S. Oncology Presence with ADC Assets
Servier Group announced a definitive agreement to acquire Day One Biopharmaceuticals, Inc. (NASDAQ: DAWN) for...
Hengrui’s Adebrelimab Wins NMPA Approval for Two Perioperative Cancer Trials – PD-L1/CTLA-4 Combo Targets Rectal and Gastric/GEJ Cancers
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced NMPA clearance for two pivotal...
Leads Biolabs’ Opamtistomig Enters Phase II in First-Line Esophageal Cancer – PD-L1/4-1BB Bispecific with BTD/ODD Designations
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced first patient enrollment in a Phase II...
CSPC’s SYH2059 Inhalation Powder Wins FDA IND Approval – PDE4B Inhibitor Targets Pulmonary Fibrosis with Enhanced Delivery
CSPC Pharmaceutical Group Ltd (HKG: 1093) announced FDA clearance to initiate a clinical study for...
AstraZeneca China Reorganizes Biopharma Operations – Omni-Channel Unit and Early Oncology Pipeline Restructuring
AstraZeneca Plc’s (AZ, NASDAQ: AZN) China unit announced a strategic reorganization of its biopharmaceutical operations,...
Haisco’s HSK39297 NMPA Filing Accepted – Oral Factor B Inhibitor Targets Paroxysmal Nocturnal Hemoglobinuria Market
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that China’s National Medical Products Administration (NMPA)...
CF PharmTech Wins NMPA Approval for Olopatadine Mometasone Combo Trial – Fixed-Dose Nasal Spray Targets Moderate-to-Severe Allergic Rhinitis
CF PharmTech Inc. (HKG: 2652) announced NMPA clearance to initiate a clinical study for its...
Dongcheng Pharma Doses First Patient in 225Ac-LNC1011 Phase I/II Trial – PSMA-Targeted Alpha Radiotherapy for Metastatic Prostate Cancer
Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced first subject enrollment in a Phase...
Bio-Thera Wins NMPA Approval for BAT8008 BAT1006 Trastuzumab Combo Trial – Dual HER2 Trop2 Targeting in Advanced Solid Tumors
Bio-Thera Solutions Ltd (SHA: 688177) announced NMPA clearance to initiate a clinical study evaluating BAT8008...
Novo Nordisk’s IcoSema Wins NMPA Approval – Once-Weekly Insulin-Semaglutide Combo Targets China Type 2 Diabetes Market
Novo Nordisk A/S (NYSE: NVO) secured NMPA approval for IcoSema, a once-weekly fixed-dose combination of...