BMS’s Augtyro Receives FDA Approval for ROS1-Positive NSCLC
The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS, NYSE: BMY)...
Drug
CDE Releases 76th Batch of Chemical Generic Reference Preparations
The Center for Drug Evaluation (CDE) has released the 76th batch of chemical generic reference...
Yipinhong Pharmacy’s AR882 Shows Promise in Gout Treatment in Phase II Study
China-based Yipinhong Pharmacy Co., Ltd (SHE: 300723) has announced positive data from a Phase II...
Easton Pharmaceutical Receives FDA Approval for Generic Nalmefene
Chengdu-based Easton Pharmaceutical Co., Ltd (SHA: 688513) has announced receiving Abbreviated New Drug Application (ANDA)...
Visen Pharmaceuticals Reports Positive Phase II Results for TransCon CNP in Achondroplasia
Visen Pharmaceuticals, a joint venture between Denmark-based Ascendis Pharma A/S (NASDAQ: ASND) and Chinese healthcare...
Vertex Pharmaceuticals and CRISPR Therapeutics Receive Conditional Approval for CRISPR Gene-Editing Therapy
Vertex Pharmaceuticals (NASDAQ: VRTX) and CRISPR Therapeutics (NASDAQ: CRSP) have received conditional approval from the...
SinoMab BioScience’s Suciraslimab IND Accepted for Review by China’s NMPA
SinoMab BioScience Ltd (HKG: 3681), a Hong Kong-based biotechnology company, has announced that the National...
Fujian Cosunter’s COVID-19 Therapy GST-HG171/Ritonavir NDA Accepted by NMPA
Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436), a China-based pharmaceutical company, has announced that its...
China’s NMPA Accepts EOC Pharma Group’s Filing for Vascepa (Icosapent Ethyl) for Review
The China-based EOC Pharma Group has achieved a significant milestone with the National Medical Products...
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)...
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...