Janssen Submits Rybrevant for FDA Review as First-Line NSCLC Treatment
Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has submitted an additional indication for review...
Drug
MSD Initiates Phase III Trial for PCSK9 Inhibitor MK-0616 in LDL Cholesterol Reduction
Merck, Sharp & Dohme (MSD; NYSE: MRK) has commenced Phase III development for its experimental...
Sandoz Receives FDA Clearance for First Biosimilar to Biogen’s Tysabri
The Sandoz unit of Switzerland-based Novartis (NYSE: NVS) has received regulatory clearance from the US...
Tasly Pharmaceuticals Gets NMPA Approval for STRO-002 Clinical Study in Solid Tumors
China-based Tasly Pharmaceuticals (SHA: 600535) has announced that it has received approval from the National...
Youcare Pharmaceutical’s YKYYO17 Receives Ethical Approval for COVID-19 Treatment Study
China-based Youcare Pharmaceutical Group (SHA: 688658) has received ethical approval from the China-Japan Friendship Hospital...
Novartis Defends Entresto Patents as Generic Approvals Trigger Legal Response
On August 24, 2023, generic versions of Novartis’ (NYSE: NVS) heart failure therapy Entresto (sacubitril,...
Jiangsu Hengrui Submits Market Approval Filing for SHR0302 in Ankylosing Spondylitis
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that a market approval filing...
Junshi Biosciences’ Senaparib NDA Accepted by NMPA for Ovarian Cancer Maintenance Treatment
China’s Junshi Biosciences (HKG: 1877; SHA: 688180) has announced that the New Drug Application (NDA)...
Jiangsu Kanion Pharmaceutical Gets NMPA Approval for SLE Clinical Trial with KYS202002A
Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557), a prominent China-based pharmaceutical company, has announced that...
Everest Medicines’ Nefecon NDA for IgAN Accepted for Review in Macao
China-based Everest Medicines (HKG: 1952) has announced that its New Drug Application (NDA) for Nefecon,...
Pfizer’s RSV Vaccine Abrysvo Receives European Commission Approval for Maternal Immunization
Pfizer (NYSE: PFE) has received registration approval from the European Commission (EC) for its respiratory...
FDA Approves Gilead’s Veklury for COVID-19 Treatment in Patients with Hepatic Impairment
The US Food and Drug Administration (FDA) has approved a new indication for Gilead’s (NASDAQ:...
AstraZeneca and MSD’s Lynparza Gets Green Light for Prostate Cancer Treatment in Japan
Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted AstraZeneca (AZ; NASDAQ: AZN) and...
CSPC Pharmaceutical’s Generic Entresto Approved in China for Heart Failure Treatment
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its generic version of Swiss...
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...
GSK’s Shingrix Proves 100% Efficacy in Phase IV Trial for Chinese Patients
UK-based pharmaceutical giant GSK plc (NYSE: GSK) has released efficacy data for its shingles vaccine,...
Dizal Pharmaceutical’s Sunvozertinib Approved by China’s NMPA for NSCLC Treatment
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that it has received market approval...
Hinova Pharmaceuticals’ HP518 for mCRPC Accepted for Review by China’s NMPA
Chengdu-based biotech company Hinova Pharmaceuticals Inc. (SHA: 688302) has announced that the National Medical Products...
Akeso Biopharma’s Ebdarokimab (AK101) NDA Accepted for Review by China’s CDE
China-based Akeso Biopharma (HKG: 9926) has announced that the New Drug Application (NDA) for its...
Eli Lilly’s Retevmo Meets Primary Endpoint in Phase III Trial for RET-mutant Medullary Thyroid Cancer
Eli Lilly (NYSE: LLY) has announced that its Phase III trial for the RET kinase...