CDE Grants Priority Review to Jiu An’s Adrenaline and AnHeart’s Taletrectinib; Two Others Earn Breakthrough Therapy Designation
The Center for Drug Evaluation (CDE) has announced that Jiu An Pharmaceutical’s adrenaline and AnHeart...
Breakthrough therapy
Bayer’s BAY 2927088 Receives FDA Breakthrough Therapy Designation for HER2-Mutated NSCLC
The US Food and Drug Administration (FDA) has granted Germany-based Bayer AG (ETR: BAYN) breakthrough...
J&J’s Gene Therapy for X-linked Retinitis Pigmentosa Receives CDE Nod for Breakthrough Designation
The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J, NYSE:...
Allist Pharmaceuticals’ Furmonertinib and AstraZeneca’s Enhertu Earn Breakthrough Designations in China for NSCLC Treatments
The Center for Drug Evaluation (CDE) in China has indicated on its website that Allist...
Staidson Pharmaceutical’s BDB-001 Earns Breakthrough Therapy Designation in China for AAV Treatment
Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a China-based pharmaceutical company, has announced that its...
Shenzhen TargetRx’s TGRX-678 Set to Receive Breakthrough Therapy Designation for CML-AP
Shenzhen TargetRx, Inc., a China-based developer of small-molecule kinase inhibitors, is poised to receive breakthrough...
Simcere Pharmaceutical’s SIM0501 Receives FDA Approval for Advanced Solid Tumor Clinical Trial
Simcere Pharmaceutical Group (HKG: 2096) has announced that it has received clinical trial approval from...
Jiangxi Jemincare’s KRAS Inhibitor Earns Breakthrough Designation from China’s CDE for NSCLC
The China Center for Drug Evaluation (CDE) website has indicated that Jiangxi Jemincare Group’s proprietary...
JW Therapeutics Secures Priority Review for Carteyva in Relapsed/Refractory Mantle Cell Lymphoma
JW Therapeutics (HKG: 2126), based in China, has announced that its CAR-T cell therapy, Carteyva...
AbbVie’s Epcoritamab Earns EMA Review and FDA Breakthrough Designation for Follicular Lymphoma
AbbVie’s (NYSE: ABBV) bispecific antibody (BsAb) Tepkinly/Epkinly (epcoritamab) has been accepted for review by the...
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),...
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:...
I-Mab and HI-Bio’s Felzartamab Earns Breakthrough Therapy Designation from US FDA
China-based I-Mab (NASDAQ: IMAB) and its US partner HI-Bio have announced that they have received...
Chongqing Precision Biotechnology’s PCAR-19B Receives CDE Nod for Breakthrough Therapy Designation
The China’s Center for Drug Evaluation (CDE) website has indicated that Chongqing Precision Biotechnology Co.,...
Allist Pharmaceuticals’ Furmonertinib Receives FDA Breakthrough Therapy Designation for NSCLC
Shanghai-based biotech Allist Pharmaceuticals Co., Ltd (SHA: 688578) has announced that it has received breakthrough...
CDE Grants Priority Review to LaNova’s LM-302, Roche’s Alectinib, and Alphamab’s KN026
China’s Center for Drug Evaluation (CDE) has indicated that LaNova Medicines’ LM-302, Roche’s (SWX: ROG)...
AcornMed Receives FDA Breakthrough Device Designation for Urothelial Carcinoma Liquid Biopsy
Beijing-based tumor precision medicine specialist, AcornMed, has been granted Breakthrough Device Designation (BDD) by the...
CDE Indicates BTD Status for Visirna’s VSA001, Sperogenix’s Vamorolone, and Zai Lab’s Efgartigimod
The Center for Drug Evaluation (CDE) website has indicated that Visirna Therapeutics’ novel siRNA therapy...
Jiangsu Hengrui’s HER2-Targeted ADC SHR-A1811 Aims for CDE’s BTD Status
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its HER2 targeted antibody-drug...
AstraZeneca and Daiichi Sankyo’s Enhertu Earns Two BTDs for HER2+ Malignancies
The US Food and Drug Administration (FDA) has granted AstraZeneca (AZ; NASDAQ: AZN) and Daiichi...