FDA Grants Accelerated Approval for Takeda’s Iclusig in Newly Diagnosed Ph+ ALL
The U.S. Food and Drug Administration (FDA) has granted accelerated indication extension approval to Japan’s...
Drug
iRegene’s NouvSight001 Gains Orphan Drug Designation for Retinitis Pigmentosa Treatment
Wuhan-based cell therapy innovator iRegene has secured Orphan Drug Designation (ODD) from the U.S. FDA...
BMS Reports Positive Phase III Results for Opdivo and Yervoy in Advanced HCC
Bristol Myers Squibb (BMS; NYSE: BMY) announced this week that its Phase III study evaluating...
Antengene’s ATG-022 Advances to Dose Expansion Phase in Phase II CLINCH Study for Solid Tumors
Antengene Corporation Ltd (HKG: 6996), a leading biopharmaceutical company based in China, has announced that...
CSPC Pharmaceutical Secures NMPA Approval for Clinical Study of SYS6023 in Advanced Solid Tumors
CSPC Pharmaceutical Group Ltd (HKG: 1093), a prominent China-based biopharmaceutical company, has received approval from...
Jiangsu Hengrui Receives NMPA Approval for Phase Ib/II Study of HRS2398 in Advanced Solid Tumors
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has...
CSPC Pharmaceutical Gets NMPA Greenlight for SYH2039 Clinical Study in Advanced Malignant Tumors
CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has received...
Everest Medicines’ Nefegan Approved by Singapore HSA for Primary IgAN Treatment
Everest Medicines (HKG: 1952), a China-based biotechnology company, has received marketing approval from the Singapore...
Dr. Reddy’s Launches Biosimilar Versavo in UK to Challenge Roche’s Cancer Therapy Avastin
Dr. Reddy’s Laboratories (NYSE: RDY), a prominent Indian pharmaceutical company, has launched its biosimilar Versavo...
Bayer’s Elinzanetant Achieves Primary Endpoint in Late-Stage Menopause Symptom Trial
Bayer (ETR: BAYN), a leading German pharmaceutical company, has announced positive results from a placebo-controlled...
China Medical System Gets Green Light for Phase III Clinical Trial of Opzelura in Atopic Dermatitis
China Medical System Holdings (CMS; HKG: 0867) has received approval from the National Medical Products...
AstraZeneca’s Lynparza-Imfinzi Combo Shows Promising Results in Endometrial Cancer Study
AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical giant, has presented interim results from a late-stage...
Teruisi Pharma’s TRS005 Receives Support for Breakthrough Designation in China for CD20-Positive Lymphoma
The Center for Drug Evaluation (CDE) in China has signaled that Teruisi Pharma’s antibody drug...
Pfizer’s Elrexfio Anticipated for Priority Review in China for Relapsed/Refractory Multiple Myeloma
The Center for Drug Evaluation (CDE) in China has indicated that Pfizer (NYSE: PFE)’s Elrexfio...
AstraZeneca Caps Monthly Costs for US Patients with Asthma and COPD Inhalers
AstraZeneca (AZ; NASDAQ: AZN), a leading UK-based pharmaceutical company, has announced an expansion of its...
Jiangsu Yahong Meditech to Present Phase III Results for Cervical Cancer Treatment at SGO Annual Meeting
Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer treatments, is...
GSK’s Jemperli Shows Survival Benefits in Phase III Endometrial Cancer Study
GlaxoSmithKline (GSK; NYSE: GSK), a leading UK pharmaceutical company, has presented early results from a...
Boehringer Ingelheim Partners with Sosei Group to Develop GPR52 Agonists for Schizophrenia
Boehringer Ingelheim (BI), headquartered in Germany, has entered into a global collaboration and exclusive option-to-license...
BeiGene’s Tislelizumab Receives FDA Approval for Esophageal Squamous Cell Carcinoma
BeiGene (NASDAQ: BGNE) has announced that the US Food and Drug Administration (FDA) has granted...
Legend Biotech’s Carvykti Earns FDA Committee’s Unanimous Recommendation for Expanded Use
GenScript Biotech Corporation (HKG: 1548), a Contract Research Organization (CRO) based in China, has announced...