FDA Extends Review Timeline for Sanofi’s Sarclisa Subcutaneous Formulation by Three Months; New Decision Date Set for July 23, 2026
The U.S. Food and Drug Administration (FDA) has extended the target action date for its...
Drug
Merck’s Idvynso Gains FDA Approval as Novel Dual-Drug HIV Treatment
Merck & Co., Inc. (MSD, NYSE: MRK) announced that the U.S. Food and Drug Administration...
Roche’s Fenebrutinib Slashes MS Relapse Rates by Over 50% in Phase III Trials
Roche AG (SWX: ROP, OTCMKTS: RHHBY) announced that its investigational non-covalent Bruton’s tyrosine kinase (BTK)...
Gan & Lee’s Nectin-4 ADC GLR1059 Clears Regulatory Hurdle for Solid Tumor Trials
Gan & Lee Pharmaceuticals Co., Ltd. (SHA: 603087) announced it has received approval from China’s...
Leads Biolabs Enrolls First Patient in Phase II Trial for Gastric Cancer Drug Opamtistomig
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced the first patient enrollment in a Phase...
Roche’s Gazyva Gains FDA Review Acceptance for Systemic Lupus Erythematosus Treatment
Roche AG (SWX: ROP, OTCMKTS: RHHBY) announced that the U.S. Food and Drug Administration (FDA)...
Daiichi Sankyo and AstraZeneca Launch Datroway ADC in China for HR-Positive, HER2-Negative Breast Cancer
Daiichi Sankyo Co., Ltd. (TYO: 4568) and AstraZeneca plc (NYSE: AZN) announced the commercial launch...
Merck and Eisai’s LITESPARK-012 Trial Fails to Meet Primary Endpoints in Advanced Kidney Cancer
Merck & Co., Inc. (MSD, NYSE: MRK) and Eisai Co., Ltd. (TYO: 4523) announced that...
AstraZeneca’s Ultomiris Shows Significant Proteinuria Reduction in Phase III IgA Nephropathy Trial
AstraZeneca plc (NYSE: AZN) announced positive results from a pre-specified interim analysis of the Phase...
CSPC’s Albumin-Bound Sirolimus (HB1901) Meets Primary Endpoint in Phase Ib/III Trial for Rare PEComa, Reinforcing Breakthrough Therapy Status
CSPC Pharmaceutical Group Ltd. (HKG: 1093) announced that its pivotal Phase Ib/III clinical trial of...
Hengrui Launches Pediatric Trial of Dual GIPR/GLP-1R Agonist HRS9531 in Overweight and Obese Adolescents Following NMPA Clearance
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) has received approval from China’s National...
Hengrui’s Trastuzumab Rezetecan Receives CDE Breakthrough Therapy Designation for First-Line HER2+ Metastatic Breast Cancer in Combination with Pertuzumab
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that its proprietary HER2-targeted antibody-drug...
Shanghai Leadingtac Secures FDA Clearance for Phase I Trial of LT-010391, First Oral KRAS-G12D Degrader in Clinical Development
Shanghai Leadingtac Pharmaceutical Co., Ltd. announced it has received U.S. Food and Drug Administration (FDA)...
FDA Grants Priority Review to Merck, Astellas, and Pfizer’s sBLA for Padcev-Pembrolizumab Combo in Perioperative Muscle-Invasive Bladder Cancer
Merck & Co. (MSD, NYSE: MRK), Astellas Pharma (TYO: 4503), and Pfizer Inc. (NYSE: PFE)...
Novo Nordisk’s Oral Etavopivat Meets Primary Endpoints in Phase III HIBISCUS Trial for Sickle Cell Disease; Regulatory Filing Planned for H2 2026
Novo Nordisk A/S (NYSE: NVO) announced positive topline results from the Phase III HIBISCUS trial...
Akeso’s Cadonilimab Shows Promise in First-Line Pancreatic Cancer at AACR 2026; Dual PD-1/CTLA-4 Bispecific Gains Guideline Endorsements Across Seven Cancers
Akeso, Inc. (HKG: 9926) announced positive Phase II data from the COMPASSION-26 trial evaluating cadonilimab,...
LEO Pharma Secures NMPA Approval for Enstilar Foam in China – First and Only Calcipotriol/Betamethasone Foam Formulation for Plaque Psoriasis Demonstrates Superior Efficacy vs. Ointment
LEO Pharma A/S has received marketing approval from China’s National Medical Products Administration (NMPA) for...
Sino Biopharmaceutical’s Subsidiary Chia Tai Tianqing Secures NMPA Approval for Benmelstobart-Anlotinib Combo in Alveolar Soft Part Sarcoma – 72.4% ORR and Unreached Median PFS in Rare Cancer Indication
The National Medical Products Administration (NMPA) has granted approval to Chia Tai Tianqing Pharmaceutical Co.,...
Hansoh Pharmaceutical Presents Promising Phase I Data for B7-H3 ADC Risvutatug Rezetecan Combined with Adebrelimab at AACR 2026 – 47.1% ORR and 14.0-Month PFS in Solid Tumors
Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) unveiled Phase I clinical trial results for risvutatug...
Eli Lilly Launches Omvoh (Mirikizumab) in China for Inflammatory Bowel Disease – IL-23p19 Antagonist Targets Ulcerative Colitis and Crohn’s Disease Following February Approval
Eli Lilly & Co. (NYSE: LLY) has officially launched Omvoh (mirikizumab) in China for the...