Japan’s MHLW Reviews GSK’s Nucala for Chronic Rhinosinusitis with Nasal Polyps Indication
The Ministry of Health, Labour and Welfare (MHLW) in Japan has begun the review process...
Drug
Eli Lilly’s Verzenios Receives NMPA Approval for Extended Indication in Early-Stage Breast Cancer
US pharmaceutical major Eli Lilly & Co., (NYSE: LLY) has announced that the National Medical...
Shanghai Junshi Biosciences’ JS207 Bispecific Antibody Receives NMPA Clinical Trial Approval
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical...
United Laboratories’ UBT251 Receives Tacit Approval for Obesity Clinical Study in China
Hong Kong-based United Laboratories International Holdings Ltd (HKG: 3933) has announced that its Category 1...
Zai Lab’s Margenza (Margetuximab) Approved by China’s NMPA for HER2-Positive Breast Cancer
The National Medical Products Administration (NMPA) website has indicated that Zai Lab Ltd’s (NASDAQ: ZLAB,...
MicuRx Pharmaceuticals Initiates Phase III Trial for MRX-4 in Complex Skin Infections
Sino-US firm MicuRx Pharmaceuticals Inc. has announced the initiation of a Phase III clinical study...
Genexine’s Eftansomatropin Alfa Achieves Phase III Endpoints in Growth Hormone Deficiency Trial
South Korea-based Genexine (KOSDAQ: 095700) has announced that its long-acting growth hormone product candidate, eftansomatropin...
AstraZeneca’s Soliris Gains Approval for Pediatric Generalized Myasthenia Gravis in Japan
UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received an...
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...
Bayer Funds Landmark Trials for Kerendia in Heart Failure Treatment Expansion
Germany-based pharmaceutical company Bayer (ETR: BAYN) has announced funding for three investigator-sponsored collaborative studies aimed...
EMA and FDA Review AbbVie’s Skyrizi for Ulcerative Colitis Indication Extension
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have accepted...
Shandong Buchang Pharmaceuticals’ BC001 for mCRC Accepted for Review by NMPA
Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), a China-based pharmaceutical company, has announced that the...
Sirnaomics’ STP707 siRNA Drug Shows Promising Results in Phase I Solid Tumor Study
Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) has revealed that all patients have been...
Servier Group’s Pancreatic Cancer Therapy Onivyde Launches in Major Chinese Cities
France-based Servier has announced the first prescriptions for its pancreatic cancer therapy, Onivyde (irinotecan), in...
Pfizer and BioNTech Receive Positive CHMP Opinion for Comirnaty Vaccine
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
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...
AIM Vaccine Co., Ltd Launches Phase III Trial for 23-Valent Pneumococcal Vaccine
China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced the commencement of a Phase III...
CSPC Pharmaceutical’s Biosimilar Ozempic Equivalent Gets NMPA Clinical Trial Approval
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its biosimilar version of Novo...
Jiangsu Yahong Meditech Gets NMPA Approval for APL1401 Ulcerative Colitis Trial
Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer based in...
Roche’s Evrysdi Receives EC Approval for Expanded Indication in Infants with SMA
Swiss pharmaceutical giant Roche (SWX: ROG) has received regulatory approval from the European Commission (EC)...