AnHeart Therapeutics and Innovent Biologics File Taletrectinib for Marketing Approval in China
China’s Center for Drug Evaluation (CDE) has indicated on its website that taletrectinib, an ROS1/NTRK...
Drug
Janssen Submits Indication Extension Application to FDA for Rybrevant in NSCLC Treatment
The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has filed an indication extension...
Fosun Pharmaceutical’s FCN-437c filing Accepted for Review by China’s NMPA
Shanghai-based Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196; SHA: 600196) has announced that the National...
CSPC Pharmaceutical’s Glumetinib Earns Breakthrough Therapy Designation in China
Glumetinib, a MET targeted tyrosine kinase inhibitor (TKI) co-developed by CSPC Pharmaceutical Group Ltd (HKG:...
BMS and 2seventy Bio’s Abecma Faces FDA Review Extension
The US Food and Drug Administration (FDA) has postponed the target action date for Bristol...
Jiangsu Aidea Pharmaceutical’s AINUOVIRINE Receives Priority Review Status from CDE
Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488), a Chinese pharmaceutical company, has announced that its...
Medilink Therapeutics’ YL201 Earns Orphan Drug Designation for Esophageal Cancer
Suzhou-based Medilink Therapeutics has announced that it has obtained orphan drug designation (ODD) from the...
BeiGene’s Brukinsa Secures Additional EU Approval for Follicular Lymphoma Treatment
BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has achieved its latest global approval for...
Ascentage Pharma Secures Additional Indication Approval for Olverembatinib from NMPA
China-based Ascentage Pharma (HKG: 6855) has announced receiving another indication approval from the National Medical...
CSPC Pharmaceutical Group Receives NMPA Approval for Phase II Clinical Study of ALMB-0168
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from...
Apollomics’ Partner Avistone Wins Conditional Approval for c-Met Inhibitor in China
US-based biotech Apollomics Inc., (NASDAQ: APLM) has announced that its Chinese partner, Beijing Avistone Pharmaceuticals...
Fosun Pharmaceutical Secures Clinical Trial Approvals for VT-101 in China and the US
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has announced receiving clinical trial approvals for...
Pfizer and Astellas Pharma Secure FDA Approval for Xtandi in High-Risk Non-Metastatic Prostate Cancer
Partners Pfizer (NYSE: PFE) and Astellas Pharma (TSE: 4503) last week received indication extension approval...
Yifan Pharmaceutical’s Subsidiary Receives FDA Approval for Ryzneuta (F-627)
China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) has announced that its subsidiary, Evive Biotech Ltd.,...
AstraZeneca Receives FDA Approval for Truqap in HR-Positive, HER2-Negative Breast Cancer
UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received regulatory...
Alphamab Oncology’s JSKN003 ADC: Promising Preliminary Data in Advanced Solid Tumors
Alphamab Oncology (HKG: 9966) has released preliminary data from a Phase I clinical study on...
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)...
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)...