Fosun Pharmaceutical Gets FDA Green Light for HLX42 ADC Clinical Study
Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196; SHA: 600196) has received approval from the US...
Drug
Pyrotech Biotechnology’s PTT-936 Gets US FDA Clinical Trial Approval
Pyrotech (Beijing) Biotechnology Co., Ltd, a China-based biotech firm, has announced that it has received...
Boehringer Ingelheim and Eli Lilly’s Jardiance Receives NMPA Approval for CKD Treatment
Boehringer Ingelheim (BI) and Eli Lilly (NYSE: LLY) have announced that their SGLT2 inhibitor, Jardiance...
Boehringer Ingelheim and Eli Lilly Secure NMPA Approval for Jardiance in Chronic Kidney Disease
Boehringer Ingelheim (BI) and Eli Lilly (NYSE: LLY) have announced the receipt of marketing approval...
MicuRx Pharmaceuticals Secures NMPA Approval for MRX-4 and Contezolid Combination Therapy
Sino-US firm MicuRx Pharmaceuticals Inc. has announced that it has received clinical trial approval from...
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)...
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...