UK MHRA Approves Eisai and Biogen’s Alzheimer’s Drug Leqembi, Despite NICE Reimbursement Rejection
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for Leqembi (lecanemab),...
Drug
Everest Medicines Launches Trial for Personalized mRNA Cancer Vaccine EVM16 in Solid Tumors
Everest Medicines, a biopharmaceutical company based in China and listed on the Hong Kong Stock...
Regeneron’s Linvoseltamab Faces FDA Complete Response Letter, Awaiting Reinspection of Manufacturer
Regeneron Pharmaceuticals Inc., a leading biopharmaceutical company based in the US and listed on the...
CK Life Sciences’ Halneuron Receives FDA Fast-Track Designation for Chemotherapy-Induced Neuropathic Pain
CK Life Sciences (HKG: 0775), a biopharmaceutical company headquartered in China, has received fast-track designation...
Innovent Biologics’ Fulzerasib Receives NMPA Approval for Advanced NSCLC Treatment in China
Innovent Biologics Inc., a biopharmaceutical company based in China and listed on the Hong Kong...
Qilu Pharmaceutical’s Biosimilar Ranibizumab Receives NMPA Approval, Marking a First in China
Qilu Pharmaceutical, a Chinese pharmaceutical company, has announced that its biosimilar version of Novartis’s blockbuster...
BrightGene Bio Receives FDA Clearance for Generic Eribulin APIs, Advancing in Breast Cancer Treatment
BrightGene Bio-Medical Technology Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange...
Daiichi Sankyo Launches Tarlige for Diabetes Peripheral Neuropathic Pain in China
Daiichi Sankyo (TYO: 4568), a leading Japanese pharmaceutical company, has announced the official market launch...
Akeso Biopharma’s Ivonescimab Earns Category 1 Recommendation in China’s 2024 Lung Cancer Clinical Guideline
Akeso Biopharma, a China-based pharmaceutical company listed on the Hong Kong Stock Exchange (HKG: 9926),...
Hangzhou Biosunpharma’s OB756 New Drug Application Accepted for Myelofibrosis Treatment by China’s NMPA
Hangzhou Biosunpharma Co., Ltd. has announced that the National Medical Products Administration (NMPA) has accepted...
Jiangsu Hansoh and GSK Receive FDA Breakthrough Designation for B7-H3 Targeted ADC in Small-Cell Lung Cancer
Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692), a prominent Chinese pharmaceutical company, and its UK...
J&J’s Rybrevant-Lazclude Combo Approved by FDA, Challenging AstraZeneca’s Tagrisso in NSCLC Treatment
Johnson & Johnson (J&J; NYSE: JNJ) has secured a new market approval in the United...
AstraZeneca’s Strensiq Approved for Rare Disease Therapy under Greater Bay Area’s Drug Access Policy
AstraZeneca (NASDAQ: AZN, LON: AZN) , a leading UK pharmaceutical company, has received approval for...
Jiangsu Hansoh Pharmaceutical and GSK Win FDA Breakthrough Therapy Designation for B7-H3 Targeted ADC in Small-Cell Lung Cancer
LONDON/HONG KONG—Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692), in collaboration with UK-based GSK plc (NYSE:...
Johnson & Johnson’s Rybrevant-Lazclude Combo Approved by FDA for First-Line NSCLC Treatment
NEW YORK—Healthcare conglomerate Johnson & Johnson (J&J; NYSE: JNJ) has secured a significant regulatory milestone...
AstraZeneca’s Strensiq Gains Approval for Rare Disease Therapy in Guangdong Under “Hong Kong-Macau Drug and Device Access”
LONDON—AstraZeneca (NASDAQ: AZN, LON: AZN) , a leading UK-based pharmaceutical company, has announced that its...
Hasten Biopharmaceutical Gains NMPA Nod for Somatostatin Marketing Rights in China
BEIJING—Hasten Biopharmaceutical Co., Ltd, a biopharmaceutical company supported by the CBC Group, has received approval...
Yipinhong Pharmacy’s AR882 Earns FDA Fast-Track Status for Gout Treatment
BEIJING—China-based Yipinhong Pharmacy Co., Ltd (SHE: 300723) has announced that its novel drug AR882 has...
Astellas Pharma’s Padcev Receives NMPA Approval for Urothelial Cancer Treatment
TOKYO—Astellas Pharma Inc. (TYO: 4503) has announced that its anti-HER3 antibody-drug conjugate (ADC), Padcev (enfortumab...
BioNTech’s BNT326/YL202 Clears FDA Hurdle, Advancing in Clinical Trials for Solid Tumor Treatment
FRANKFURT—BioNTech SE (NASDAQ: BNTX), a leading German biotechnology company, has announced that the US Food...