C2 Pharma Secures C-DMF Approval for Pilocarpine Nitrate API
Ireland-based C2 Pharma has announced the receipt of approval for a C-DMF (drug master file)...
Drug
SCG Cell Therapy’s SCG101 Receives Tacit Approval for Cholangiocarcinoma Clinical Trial in China
China’s Center for Drug Evaluation (CDE) website has indicated that SCG Cell Therapy Pte. Ltd’s...
Akeso Biopharma’s Cadonilimab Meets Primary Endpoint in Phase III Cervical Cancer Study
China-based Akeso Biopharma (HKG: 9926) has announced that its Phase III AK104-303 study for cadonilimab...
RemeGen’s Telitacicept Receives Full Approval for Systemic Lupus Erythematosus in China
China-based pharmaceutical company RemeGen (HKG: 9995) has announced the conversion of conditional approval to complete...
Bayer Halts Late-Stage Trial for Asundexian After Underperformance
Germany-headquartered Bayer (ETR: BAYN) announced the termination of a late-stage trial for its antithrombotic candidate...
Brii Biosciences’ BRII-179 Vaccine on Track for Breakthrough Therapy Designation in China
China’s Center for Drug Evaluation (CDE) website has indicated that Brii Biosciences Ltd (HKG: 2137),...
Sumitomo Pharma Receives Chinese Approval for Xenleta to Treat Pneumonia
Japan-based Sumitomo Pharma Co., Ltd (OTCMKTS: DNPUF) has secured market approval in China for Xenleta...
Gilead Announces Low-Carbon Bronchodilator Study for H1 2024
Gilead Sciences Inc. (NASDAQ: GILD) has announced plans for a Phase III study in the...
Hunan Warrant Pharmaceutical’s ZG-001 Approved for Clinical Trial by NMPA
Hunan Warrant Pharmaceutical Co., Ltd (SHA: 688799), a China-based pharmaceutical company, has announced receiving clinical...
VivaVision Biotech Inc. Receives FDA Approval for VVN461 Phase II Clinical Trial
China’s VivaVision Biotech Inc. has announced that it has received approval from the US Food...
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...
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...