Amgen’s Tarlatamab Receives FDA Priority Review for Advanced Small Cell Lung Cancer Treatment
The US Food and Drug Administration (FDA) has granted priority review status to Amgen (NASDAQ:...
Priority reviews
HutchMed’s Sovleplenib Set for Priority Review in China for Chronic Immune Thrombocytopenia
China’s Center for Drug Evaluation (CDE) has indicated that HutchMed (China) Ltd (NASDAQ: HCM; HKG:...
Eli Lilly’s Jaypirca Receives FDA Accelerated Approval for Chronic Lymphocytic Leukemia
The US Food and Drug Administration (FDA) has granted Eli Lilly (NYSE: LLY) an accelerated...
Roche’s Mosunetuzumab and AnHeart’s Taletrectinib Poised for Priority Review in China
The China Center for Drug Evaluation (CDE) website has indicated that Roche’s (SWX: ROG) Lunsumio...
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...
AstraZeneca Receives FDA Approval for Truqap in HR-Positive, HER2-Negative Breast Cancer
UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received regulatory...
BMS’s Augtyro Receives FDA Approval for ROS1-Positive NSCLC
The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS, NYSE: BMY)...
Eli Lilly’s Donanemab on Track for Priority Review in China for Early-Stage Alzheimer’s
The China’s Center for Drug Evaluation (CDE) website has indicated that Eli Lilly’s (NYSE: LLY)...
Enhertu Receives Priority Review Status for HER2-Positive Gastric Cancer Treatment in China
The Center for Drug Evaluation (CDE) website has indicated that Enhertu (trastuzumab deruxtecan), a HER2-targeted...
BeiGene’s ZW25 on Track for Priority Review for Cholangiocarcinoma Treatment by CDE
The Center for Drug Evaluation (CDE) website has indicated that BeiGene’s (NASDAQ: BGNE) ZW25 (zanidatamab)...
Sichuan Kelun-Biotech’s SKB264 Receives Priority Review Status for TNBC Treatment in China
The China’s Center for Drug Evaluation (CDE) website has indicated that Sichuan Kelun-Biotech Biopharmaceutical Co.,...
Jenscare Scientific’s Ken Valve Enters NMPA Priority Review for Aortic Valve System
Jenscare Scientific Co., Ltd (HKG: 9877), a leading structural heart disease device manufacturer based in...
Innovent Biologics’ GFH925 on Track for Priority Review Status for NSCLC Treatment
The Center for Drug Evaluation (CDE) has indicated that Innovent Biologics’s (HKG: 1801) Category 1...
CDE Grants Priority Review to Pearl Biotech’s Breatinib for Glioblastoma Treatment
China’s Center for Drug Evaluation (CDE) has indicated that Beijing Pearl Biotechnology Co., Ltd’s breatinib...
Pfizer’s Cibinqo and Everest Medicines’ Cefepime-Taniborbactam Selected for Priority Reviews by CDE
The Center for Drug Evaluation (CDE) has indicated on its website that Pfizer’s (NYSE: PFE)...
FDA Grants Priority Review to MSD’s Welireg for Advanced RCC Indication Extension
The US Food and Drug Administration (FDA) has granted priority review status to an indication...
Henan Zhongshuai’s Dexmethylphenidate Hydrochloride Capsules Target Priority Review for Pediatric ADHD
Henan Zhongshuai Pharmaceutical Co., Ltd., a China-based pharmaceutical company, is poised to secure priority review...
Novo Nordisk’s Esperoct on Track for Priority Review in Hemophilia A Treatment
The Center for Drug Evaluation (CDE) website has indicated that Denmark-based Novo Nordisk’s (NYSE: NVO)...
Dizal Pharmaceutical’s Golidocitinib Earns Priority Review for r/r PTCL Treatment in China
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that its drug golidocitinib has been...
Akeso Biopharma’s Ivonescimab Heads for Priority Review for NSCLC Treatment
China-based Akeso Biopharma (HKG: 9926) has announced that its bispecific antibody (BsAb) ivonescimab (AK112), targeting...