Takeda Receives FDA Approval for ORZEYFUL (oveporexton), First Oral OX2R Agonist for Narcolepsy Type 1 in Adults
Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that the U.S. Food and Drug...
Drug
Shandong Boan Biotech Submits BLA to Brazil’s ANVISA for Aflibercept Biosimilar BA9101, Expanding Global Ophthalmic Footprint
Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced the submission of a Biologics License Application...
Eli Lilly’s KRAS G12C Inhibitor Olomorasib Receives Second FDA Breakthrough Therapy Designation for Advanced Pancreatic Cancer
Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA)...
CSPC Pharmaceutical’s NDA for Anbenitamab-HB1801 Combination Accepted by China NMPA as Neoadjuvant Therapy for HER2+ Breast Cancer
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that the New Drug Application (NDA) for its...
Leads Biolabs’ Trispecific T-Cell Engager LBL-051 Enters Phase Ia Trial for Refractory Autoimmune Diseases Through Oblenio Bio Partnership
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced that Oblenio Bio, a NewCo jointly established...
Allergan Aesthetics’ BOTOX Cosmetic sBLA Accepted by FDA for Masseter Muscle Prominence, Poised to Become First Neurotoxin Indication
Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), announced that the U.S. Food and Drug...
Sino Biopharmaceutical’s BCL-2 Inhibitor TQB3909 Tablet Receives CDE Acceptance for CLL/SLL Treatment in Relapsed/Refractory Patients
Sino Biopharmaceutical Limited (HKG: 1177) announced that its subsidiary Chia Tai Tianqing Pharmaceutical (CTTQ)‘s New...
Haixi Pharma’s Oral nAMD Drug Candidate HX9428 Receives FDA Clearance for Phase 2 Trials, Offering Alternative to Intravitreal Injections
Fujian Haixi Pharmaceuticals Co., Ltd. (HKG: 2637) announced that the Investigational New Drug (IND) application...
Sanofi Secures European Commission Approval for MenQuadfi Pediatric Indication Extension to Infants from Six Weeks of Age
Sanofi (NASDAQ: SNY) announced that the European Commission (EC) has approved an extension of the...
Alphamab Oncology’s Anbenitamab NDA Accepted by China NMPA for HER2+ Breast Cancer Neoadjuvant Treatment, Granted Priority Review
Alphamab Oncology (HKG: 9966) announced that the New Drug Application (NDA) for Anbenitamab (trade name:...
CARsgen Therapeutics’ CT0596 Receives NMPA Clinical Approval for Relapsed/Refractory Multiple Myeloma
CARsgen Therapeutics (HKG: 2171) announced that CT0596 has received clinical approval from the National Medical...
InnoCare Pharma’s Orelabrutinib-Mesutoclax Combination Receives Breakthrough Therapy Designation for Marginal Zone Lymphoma
InnoCare Pharma Limited (HKG: 9969, SHA: 688428) announced that the combination regimen of orelabrutinib and...
Adlai Nortye’s AN4035 Receives Australian Regulatory Approvals for First-in-Class Pan-RAS(ON) ADC
Adlai Nortye (NASDAQ: ANL) announced that the company’s independently developed antibody-drug conjugate (ADC) AN4035, which...
Zai Lab’s Zocilurtatug Pelitecan Receives FDA Orphan Drug Designation for Neuroendocrine Carcinoma
Zai Lab (NASDAQ: ZLAB; HKG: 9688) announced that the US Food and Drug Administration (FDA)...
FDA Grants Biologics License to Ezplaz Freeze-Dried Plasma, First FDP Approved in United States
On July 29, 2026, the U.S. FDA granted a biologics license to Ezplaz Freeze Dried...
Novartis’ Pluvicto Receives FDA Approval for Metastatic Hormone-Sensitive Prostate Cancer
Novartis (NYSE: NVS) announced that the U.S. Food and Drug Administration (FDA) has approved Pluvicto...
Sino Biopharmaceutical’s TQB2102 Receives Breakthrough Therapy Designation from NMPA for HER2-Low Breast Cancer
Sino Biopharmaceutical Limited (HKG: 1177) announced that its subsidiary Chia Tai Tianqing Pharmaceutical (CTTQ)‘s TQB2102,...
Suzhou Forlong Biotechnology Advances FL115 Subcutaneous Injection into Phase 1 Clinical Trial for Advanced Solid Tumors
Suzhou Forlong Biotechnology Co., Ltd. announced that FL115 subcutaneous injection (administered once every three weeks)...
Shaanxi Micot Pharmaceutical Announces Positive Phase 2 Results for MT200605 in Acute Ischemic Stroke
Shaanxi Micot Pharmaceutical Technology Co., Ltd. (HKG: 2335) announced that its independently developed drug candidate...
CSPC Pharmaceutical Launches Phase Ib/II Trial of Novel SYS6090 Fusion Protein for Colorectal Cancer
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that a Phase Ib/II clinical trial of SYS6090...