EMA’s CHMP Issues Positive Opinion for Roche’s Tecentriq SC Subcutaneous Formulation
The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA)...
Drug
Eli Lilly’s Donanemab on Track for Priority Review in China for Early-Stage Alzheimer’s
The China’s Center for Drug Evaluation (CDE) website has indicated that Eli Lilly’s (NYSE: LLY)...
Bayer Withdraws Aliqopa FDA Filing Following Missed Phase III Endpoint
Germany-based pharmaceutical major Bayer (ETR: BAYN) has announced its decision to withdraw the filing for...
Servier’s Tibsovo Receives FDA Approval for IDH1-Mutated R/R MDS, Expanding Indications
France-based pharmaceutical company Servier has announced that the US Food and Drug Administration (FDA) has...
Huadong Medicine’s Arcalyst (Rilonacept) Filing for CAPSs Accepted by China’s NMPA
Huadong Medicine Co., Ltd (SHE: 000963), a China-based pharmaceutical company, has announced that the National...
Jiangsu Hengrui Pharmaceuticals’ HR20031 Accepted for Review by China’s NMPA for Type 2 Diabetes
Jiangsu Hengrui Pharmaceuticals (SHA: 600276), a leading Chinese pharmaceutical company, has announced that the National...
AstraZeneca’s Imfinzi Gains NMPA Approval for First-Line Cholangiocarcinoma Treatment
The National Medical Products Administration (NMPA) of China has indicated on its website that it...
Hansoh Pharmaceutical’s HS-10511 Tablets for Hypertrophic Cardiomyopathy Cleared for Clinical Trials
Hansoh Pharmaceutical (HKG: 3692) has announced that its affiliated company’s self-developed Class 1 new drug,...
Novo Nordisk Commits Over DKK 42 Billion to Expand Chronic Disease Production in Denmark
Novo Nordisk (CPH: NOVO-B), a leading pharmaceutical company, last week announced a substantial plan to...
Clinical Research on rAAV Gene Drug ZS805 for Fabry Disease Launched by Zhishan Weixin
Zhishan Weixin Biotechnology Co., Ltd, a China-based biotech company, has announced the launch of the...
Jiangsu Hengrui Pharmaceuticals’ Subsidiary Shengdi Pharmaceuticals Receives NMPA Approval for HRS-9057
Jiangsu Hengrui Pharmaceuticals (SHA: 600276), a leading pharmaceutical company in China, has announced that its...
Beijing Aosaikang’s Combo Therapy for NSCLC Accepted for Clinical Trial by NMPA
Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755), a Chinese pharmaceutical company, has announced that the...
China’s NMPA Grants Conditional Approval for Juventas’ CAR-T Therapy Inaticabtagene Autoleucel
The National Medical Products Administration (NMPA) has conditionally approved the marketing of inaticabtagene autoleucel (CNCT...
Eli Lilly’s Zepbound Approved by FDA for Chronic Weight Management in Adults
Eli Lilly (NYSE: LLY) has received registration approval from the US Food and Drug Administration...
Yantai Dongcheng Pharmaceutical Gets Singapore HSA Nod for Phase I Study of 177Lu-LNC1003
China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced receiving approval from the...
Chongqing Lummy Pharmaceutical’s Generic Ramosetron Passes GQCE in China
China-based Chongqing Lummy Pharmaceutical Co., Ltd (SHE: 300006) has announced that its generic version of...
Sirius Therapeutics Pursues First-in-Human Trial for SRSD107 in Australia
Sino-US biotech Sirius Therapeutics has announced its pursuit of Investigational New Drug (IND) approval in...
ImmVira’s MVR-T3011 IV Achieves Positive Outcomes in US Phase I Clinical Study
Shenzhen-based biotechnology company ImmVira has announced the successful completion of Phase I clinical studies in...
Novartis’ Remibrutinib Meets Milestones in Late-Stage Chronic Spontaneous Urticaria Studies
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that two late-stage studies for its Bruton’s...
Roche’s Lymphoma Therapy Columvi Receives NMPA Approval for Adult Patients with Relapsed DLBCL
Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has received market approval from...