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...
Drug
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...
Changchun High & New Technology Secures NMPA Approval for Turner Syndrome Treatment
CHANGCHUN—Changchun High & New Technology Industries (Group) Inc., (SHE: 000661), a leading biopharmaceutical company in...
AstraZeneca’s Fasenra Secures NMPA Approval for Severe Eosinophilic Asthma Maintenance Therapy
BEIJING—The National Medical Products Administration (NMPA) of China has granted market approval for AstraZeneca (NASDAQ:...
Genmab’s Tepkinly/Epkinly Receives EC Nod for Relapsed Lymphoma Treatments
COPENHAGEN—Genmab A/S (NASDAQ: GMAB), a leading biotech company, has announced that the European Commission (EC)...
Beijing Proposes New Regulations to Enhance Pharmaceutical Retail Standards and Services
The Beijing Municipal Medical Products Administration has unveiled a draft proposal titled “Guiding Opinions on...
AstraZeneca’s Imfinzi Gains FDA Approval for Neoadjuvant Use in Early-Stage Lung Cancer
AstraZeneca (NASDAQ: AZN, LON: AZN) , the UK-based pharmaceutical powerhouse, has secured US FDA approval...
Sichuan Biokin Launches Phase III Trial for Bispecific ADC BL-B01D1 in Lung Cancer
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) has commenced the first patient dosing in a...
Yixintang Partners with Huawei Cloud to Drive Digital Transformation in Pharma Retail
Yixintang Pharmaceutical Group Co., Ltd. (SHE: 002727), a prominent pharmaceutical retail chain in China, has...
CARsgen Completes Patient Enrollment for Phase II Trial of CT041 in Advanced Gastric Cancer
CARsgen Therapeutics Holdings Ltd (HKG: 2171), a leading China-based developer of chimeric antigen receptor (CAR)-T...
Kelun Pharmaceutical’s Sacituzumab Tirumotecan Receives Priority Review for NSCLC Treatment
Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422) has announced that its drug sacituzumab tirumotecan (SKB264/MK-2870)...
Lykos Therapeutics Faces Setback as FDA Rejects Midomafetamine for PTSD Treatment
Lykos Therapeutics, a U.S.-based biotech firm, has expressed concern over the impact of the FDA’s...
Chugai Seeks Approval for Elevidys Gene Therapy in Japan, Targeting Duchenne Muscular Dystrophy
Chugai Pharmaceutical Co., Ltd. (TYO: 4519), a subsidiary of Roche, has submitted a product approval...