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,...
Drug
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...
FDA Grants Priority Review to Pfizer and Astellas’ Xtandi for High-Risk Prostate Cancer
The US Food and Drug Administration (FDA) has granted priority review status to the submission...
Nanjing F&S Pharmatech Secures First Generic Approval for Novartis’s Entresto in China
Nanjing F&S Pharmatech Co., Ltd, a China-based pharmaceutical company, has announced that it has received...
Lynk Pharmaceuticals’ LNK01001 Shows Positive Results in Ankylosing Spondylitis Phase II Study
China-based Lynk Pharmaceuticals Co., Ltd has announced positive topline results from the Phase II clinical...
Allist Pharmaceuticals’ Furmonertinib Wins NMPA Nod for EGFR-Mutated NSCLC Treatment
Shanghai-based Allist Pharmaceuticals Inc. (SHA: 688578) has announced that it has received clinical approval from...
Zai Lab’s Repotrectinib Targets Breakthrough Therapy Designation for TRK-Positive Tumors
The Center for Drug Evaluation (CDE) website has indicated that repotrectinib, a next-generation ROS1/TRK/ALK tyrosine...
RemeGen’s Telitacicept Shows Positive Phase III Results in Rheumatoid Arthritis Study
China-based RemeGen Co., Ltd (HKG: 9995, SHA: 688331) has announced positive results from the China...
Roche Subsidiary Genentech Addresses Accidental Disclosure of Tiragolumab Trial Data
Swiss pharmaceutical major Roche (SWX: ROG), through its subsidiary Genentech, has released a statement addressing...
European Commission Grants Conditional Approval for Janssen’s Talvey in Multiple Myeloma
The European Commission (EC) has granted conditional approval to Johnson & Johnson’s (J&J; NYSE: JNJ)...
Jiangsu Hengrui Pharmaceuticals’ Fluzoparib Files for New Indication with China’s NMPA
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that the National Medical Products...