Mirxes Holding Company Receives FDA Breakthrough Device Designation for GASTROClea
Singapore-based RNA technology company, Mirxes Holding Company Ltd, which specializes in blood-based miRNA test kit...
Breakthrough therapy
Suzhou Jiecheng Medical Secures FDA BDD for Transvascular Aortic Valve Treatment
Suzhou Jiecheng Medical Technology Co., Ltd has announced that it has obtained Breakthrough Devices Designation...
Jacobio Pharma’s Glecirasib Enters Breakthrough Therapy Review for Pancreatic Cancer Treatment
China-based Jacobio Pharma (HKG: 1167) has announced that its novel KRAS G12C inhibitor, glecirasib, has...
Eli Lilly’s Mirikizumab and Chia Tai Tianqing’s Lanifibranor Enter Breakthrough Therapy Review
US pharmaceutical major Eli Lilly’s (NYSE: LLY) mirikizumab and China-based Chia Tai Tianqing’s lanifibranor have...
HutchMed’s Elunate-Tyvyt Combo Receives Breakthrough Therapy Designation in China for Endometrial Cancer
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) has announced that the combination of Elunate (fruquintinib)...
TransThera Sciences’ TT-00420 Receives Breakthrough Designation for Cholangiocarcinoma Treatment
The Center for Drug Evaluation (CDE) website has indicated that Nanjing-based TransThera Sciences (Nanjing), Inc.’s...
Sichuan Kelun’s SKB264 Earns Breakthrough Therapy Designation for Breast Cancer Treatment
The Center for Drug Evaluation (CDE) website has indicated that China-based Sichuan Kelun Pharmaceutical Co.,...
CDE Considers Breakthrough Therapy Designation for Beijing Mabworks’ MIL162 and Amgen’s AMG 890
The Center for Drug Evaluation (CDE) website indicates that China-based Beijing Mabworks Biotech Co., Ltd’s...
Ascentage Pharma’s Olverembatinib Earns Breakthrough Designation for SDH-Deficient GIST
The China’s Center for Drug Evaluation (CDE) has granted breakthrough therapy designation (BTD) to olverembatinib,...
Huadong Medicine’s Mefatinib Poised for Breakthrough Therapy Designation by CDE
The Center for Drug Evaluation (CDE) website indicates that China-based Huadong Medicine Co., Ltd (SHE:...
Innovent Biologics’ GFH925 Earns Breakthrough Therapy Designation for KRASG12C CRC Treatment
The Center for Drug Evaluation (CDE) website indicates that China-based Innovent Biologics’ (HKG: 1801) Category...
Fosun Pharmaceutical’s FCN-159 Earns Breakthrough Therapy Designation for Histiocyte Tumors
The Center for Drug Evaluation (CDE) website has announced that Shanghai Fosun Pharmaceutical (Group) Co.,...
Priority Review Status Anticipated for HH-003, BI655130, VIS649, and Remternetug by CDE
The Center for Drug Evaluation (CDE) website has indicated that Huahui Health’s HH-003, Boehringer Ingelheim’s...
Johnson & Johnson’s Talquetamab on Track for Breakthrough Therapy Designation in Multiple Myeloma
China’s Center for Drug Evaluation (CDE) has indicated that US pharmaceutical giant Johnson & Johnson’s...
Pfizer’s Ritlecitinib Heads for Priority Review in China for Vitiligo Treatment
The China’s Center for Drug Evaluation (CDE) website has indicated that Pfizer’s (NYSE: PFE) ritlecitinib,...
CDE Grants Priority Review Status to TQB3454, HLX208, and Infigratinib for Cancer Treatments
The Center for Drug Evaluation (CDE) website has indicated that Chia Tai Tianqing’s TQB3454, Henlius...
Advenchen Lab’s AL8326 and Hengrui’s SHR-A1811 Receive Breakthrough Therapy Designations
The Center for Drug Evaluation (CDE) website indicates that Advenchen Lab’s AL8326 and Hengrui Pharmaceuticals’...
Novartis’ LNP023 and Janssen’s Tremfya on Track for Breakthrough Designations
The Center for Drug Evaluation (CDE) website indicates that Swiss major Novartis’ (NYSE: NVS) LNP023...
Kelun’s SKB264 Receives Breakthrough Therapy Designation for Lung Cancer
Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced that its antibody-drug conjugate (ADC) SKB264,...
Abbisko’s ABSK021 Receives FDA Breakthrough Therapy Designation for TGCT
Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving breakthrough therapy designation (BTD)...