First Patient Dosed in Abbisko’s Phase II Trial of ABSK061 and ABSK043 in FGFR2/3 Altered Tumors
Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the first patient dosing in...
Drug
Bayer’s Nubeqa Files for FDA Approval in mHSPC
German pharmaceutical company Bayer AG (ETR: BAYN) has announced that the US Food and Drug...
China Grants Marketing Approval for MSD’s Welireg for von Hippel-Lindau Disease Tumors
China’s National Medical Products Administration has issued marketing approval for Merck, Sharp & Dohme’s (MSD;...
Easton Pharmaceutical Secures NMPA Approval for Generic Jakavi and Urocit-K
Chengdu-based Easton Pharmaceutical Co., Ltd (SHA: 688513) has announced that it has received separate marketing...
Innorna’s mRNA Drug IN015 Earns Orphan Drug Designation for PFIC Treatment
Shenzhen-based Innorna Co., Ltd, a leading platform company specializing in mRNA technology and LNP (lipid...
Jiangsu Hengrui Receives NMPA Approval for HRS-6208 Solid Tumor Clinical Study
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from...
InxMed’s Ifebemtinib Earns Breakthrough Therapy Designation for NSCLC Treatment in China
China-based InxMed (Nanjing) Co., Ltd has announced that the Center for Drug Evaluation of the...
Hua Medicine and Bayer AG Terminate Co-promotion Agreement for HuaTangNing
China-based Hua Medicine (HKG: 2552) has announced the termination of its co-promotion agreement with German...
Sino Biopharmaceutical Submits NDA for Anlotinib and Penpulimab Combo in HCC to NMPA
China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced the submission of a New Drug Application...
Innovent Biologics’ IBI354 Earns Breakthrough Therapy Designation for Ovarian Cancer Treatment
The Center for Drug Evaluation (CDE) website has indicated that China-based Innovent Biologics, Inc. (HKG:...
CDE Includes Double-Crane’s Hydroxocobalamine and Sanofi Genzyme’s Fitusiran in Rare Disease Care Plan
China’s Center for Drug Evaluation (CDE) has announced the inclusion of China Resources Double-Crane Pharmaceutical...
Apeiron Therapeutics Initiates Phase Ia/B Study for GTA182 in Solid Tumors with MTAP Deficiency
Apeiron Therapeutics, a biomarker-driven cancer therapy developer with operations in Shanghai, China, and San Francisco,...
NMPA Approves Alpha Biopharma’s Zorifertinib for First-Line NSCLC Treatment with CNS Metastases
The National Medical Products Administration (NMPA) has granted approval to China-based Alpha Biopharma’s zorifertinib, commercially...
Pfizer’s Hympavzi Receives European Commission Approval for Hemophilia A and B
US pharmaceutical major Pfizer Inc. (NYSE: PFE) has announced that the European Commission (EC) has...
Guangdong Zhongsheng Pharmaceutical’s RAY1225 Shows Positive Results in Phase II Study
Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a China-based pharmaceutical company, has announced positive top-line...
US FDA Grants ODD to Ractigen’s siRNA Therapy RAG-21 for ALS Treatment
China-based small activating RNA (saRNA) drug developer, Ractigen Therapeutics, has announced that it has received...
UCB’s Bimzelx Receives US FDA Approval for Moderate to Severe Hidradenitis Suppurativa
Belgium-based biopharmaceutical company UCB (FRA: UNC) has announced that the US Food and Drug Administration...
GSK’s Linerixibat Demonstrates Efficacy in Phase III GLISTEN Study for Cholestatic Pruritus
UK-based pharmaceutical giant GlaxoSmithKline (GSK; NYSE: GSK) has announced positive headline results from the Phase...
Astellas Pharma’s Izervay sNDA for Geographic Atrophy Receives FDA Complete Response Letter
Japan-based Astellas Pharma Inc. (TYO: 4568) has announced that its supplemental New Drug Application (sNDA)...
MSD Announces Positive Topline Results from Phase III Subcutaneous Keytruda Trial
US-based Merck, Sharp & Dohme Inc., (MSD, NYSE: MRK) has released positive topline results from...