CanSino Biologics’ DTcP Vaccine for Infants Gains Priority Review in China
China-based vaccines specialist CanSino Biologics Inc. (HKG: 6185) announced that the New Drug Application (NDA)...
Priority reviews
Boehringer Ingelheim’s Nerandomilast Granted Priority Review for IPF in China
German pharmaceutical giant Boehringer Ingelheim has announced that the Center for Drug Evaluation (CDE) of...
FDA Grants Priority Review to Johnson & Johnson’s Nipocalimab for Myasthenia Gravis
US-based Johnson & Johnson (J&J, NYSE: JNJ) has announced that the US FDA has granted...
Dizal’s Sunvozertinib Receives Priority Review from FDA for EGFR Exon 20 NSCLC
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that its New Drug Application (NDA)...
Huahui Health’s HH-003 Gains Priority Review Status for Chronic Hepatitis D Treatment
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has indicated...
CDE Indicates Priority Review for Boehringer Ingelheim’s Zongertinib and Peers
The China’s Center for Drug Evaluation (CDE) website has indicated that several drugs, including German...
GSK’s Blenrep and Star Pharma’s Topiramate Solution Target Priority Review in China
The China’s Center for Drug Evaluation (CDE) website has signaled that GlaxoSmithKline’s (GSK; NYSE: GSK)...
Ascentage Pharma’s Lisaftoclax and AceLink Therapeutics’ AL01211 Receive FDA Designations
The Center for Drug Evaluation (CDE) website has indicated that China-based Ascentage Pharma’s (HKG: 6855)...
Daiichi Sankyo’s Pexidartinib Poised for Priority Review in China for TGCT Treatment
The official website of the Center for Drug Evaluation (CDE) under China’s National Medical Products...
Jiangsu Hengrui’s SHR2554 Gets Priority Review for Lymphoma Treatment, Strengthening Global EZH2 Inhibitor Market
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) is on the brink of a breakthrough in...
CDE Lists Five Drugs and One Companion Diagnostic for Priority Review Status
The Center for Drug Evaluation (CDE) has indicated on its website that five investigational drugs...
Sinopharm and Ruidio Pharmaceutical Advance in Priority Review for Innovative Drugs and Vaccines
BEIJING—The Center for Drug Evaluation (CDE) has indicated that two Chinese companies, Foshan Ruidio Pharmaceutical...
Kelun Pharmaceutical’s Sacituzumab Tirumotecan Receives Priority Review for NSCLC Treatment
Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422) has announced that its drug sacituzumab tirumotecan (SKB264/MK-2870)...
Wantai Biological’s HPV Vaccine Receives Priority Review from China’s CDE
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392) has announced that its nine-valent recombinant...
Belief BioMed’s Hemophilia B Gene Therapy BBM-H901 Slated for Priority Review in China
The Center for Drug Evaluation (CDE) has indicated on its website that the market application...
HutchMed’s Tazverik for Follicular Lymphoma Accepted for Review by China’s NMPA
HutchMed (NASDAQ: HCM), a China-based biopharmaceutical company, has announced that the National Medical Products Administration...
Johnson & Johnson’s Talvey Gets Green Light in South Korea for Multiple Myeloma
Johnson & Johnson (J&J; NYSE: JNJ) has announced that its subsidiary Janssen Korea has received...
InnoCare’s Tafasitamab-Lenalidomide Combo on Track for Priority Review in China for DLBCL Treatment
The Center for Drug Evaluation (CDE) website has indicated that InnoCare (HKG: 9969; SHA: 688428),...
Keymed Biosciences’ Stapokibart Earns Priority Review for Chronic Sinusitis Treatment in China
Keymed Biosciences Inc., (HKG: 2162), a biopharmaceutical company based in China, has announced that its...
Jacobio Pharma’s Gecirasib Gets Priority Review for NSCLC Treatment by China’s NMPA
Jacobio Pharma (HKG: 1167), a leading biopharmaceutical company based in China, has announced that its...