Pfizer and Genmab’s Tivdak Earns Priority Review from FDA for Full Registration
The US Food and Drug Administration (FDA) has accepted for priority review a filing from...
Drug
AbbVie Launches Continuous Infusion Therapy for Advanced Parkinson’s Disease in EU
AbbVie (NYSE: ABBV) has announced the launch of its dopamine replacement therapy, Produodopa (foslevodopa +...
OBI Pharma Gets US FDA Green Light for TROP2 Targeting ADC Cancer Therapy Clinical Study
OBI Pharma (4174.TWO), partner to Biosion Inc., has announced that it has received approval from...
MSD’s Gardasil 9 Receives NMPA Approval for Two-Dose Schedule in Younger Females
Merck, Sharp & Dohme (MSD; NYSE: MRK), a prominent pharmaceutical company in the U.S., has...
Astellas’ Zolbetuximab Faces FDA Rejection Due to Manufacturing Facility Deficiencies
The US Food and Drug Administration (FDA) has issued a rejection for a filing submitted...
3SBio Inc. Receives NMPA Approval for OTC Minoxidil Foam for Male Hair Loss Treatment
3SBio Inc., a leading biopharmaceutical company based in China (HKG: 1530), has announced that it...
Jiangxi Jemincare Group Receives Clinical Trial Approvals for Two Innovative Biologics in the US and China
Jiangxi Jemincare Group, a biopharmaceutical company based in China, has announced that it has received...
Allist Pharmaceuticals’ Furmonertinib and AstraZeneca’s Enhertu Earn Breakthrough Designations in China for NSCLC Treatments
The Center for Drug Evaluation (CDE) in China has indicated on its website that Allist...
Thederma’s TAP-1503 Cream Receives Priority Review Status for Pediatric Atopic Dermatitis Treatment in China
The Center for Drug Evaluation (CDE) website has indicated that China-based Thederma’s TAP-1503 cream is...
Innovent Biologics’ Mazdutide Achieves Positive Results in Phase III Clinical Trial for Overweight or Obesity
Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that...
Abbisko Therapeutics’ Pimicotinib Earns Orphan Drug Designation from EMA for TGCT Treatment
Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology company, has announced that it has...
Gilead’s Descovy Receives Additional Indication Approval from China’s NMPA for HIV-1 PrEP
Gilead Sciences, Inc. (NASDAQ: GILD), a major player in the pharmaceutical industry in the U.S.,...
CSBIO’s Multi-Kinase Inhibitor CSCJC3456 Gets Green Light for Clinical Trials in Advanced Solid Tumors
Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255), a Chinese pharmaceutical company, has announced...
Aidea Pharmaceutical Receives NMPA Approval to Clinically Test HIV-1 Treatment ACC017
Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488), a pharmaceutical company based in China, has announced...
Hengrui Pharmaceuticals Gets NMPA Green Light for Phase Ib/II Study of SHR-A1921 Combo in Advanced Solid Tumors
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from...
MSD Advances Four Oncology Candidates to Late-Stage Trials, Including Partnerships with Kelun-Biotech and Orion
Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced significant progress in its oncology pipeline...
BMS’s Abraxane Approved in China for First-Line Metastatic Pancreatic Cancer Treatment
Bristol Myers Squibb (BMS, NYSE: BMY), a leading U.S. pharmaceutical company, has announced that it...
Jiangsu Hengrui Pharmaceuticals Wins NMPA Nod for SGLT-2 Inhibitor and Metformin Combo for Type 2 Diabetes
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced...
Genrix Bio Seeks China Approval for New Xeligekimab Use in Axial Spondyloarthritis
Chongqing Genrix Biopharmaceutical Co., Ltd. (SHA: 688443), a biopharmaceutical company based in China, has submitted...
Akeso Biopharma Submits New Indication Application for Cadonilimab in Gastric Cancer Treatment
Akeso Biopharma (HKG: 9926), a leading biopharmaceutical company based in China, has announced the submission...