Eli Lilly’s Kisunla (Donanemab) Receives FDA Label Update with New Dosing Schedule for Alzheimer’s Treatment
US pharmaceutical giant Eli Lilly & Co. (NYSE: LLY) has announced that the US Food...
Product approvals
Innovent’s Dabote Becomes First China-Originated KRAS G12C Inhibitor Approved in Macau
China-based biopharma leader Innovent Biologics Inc. (HKG: 1801) has announced a significant regulatory milestone with...
Novartis’ Coartem Baby Approved by Swissmedic for Newborns and Young Infants
Swiss pharmaceutical giant Novartis (NYSE: NVS) announced that it has received marketing approval from Swissmedic...
Boston Scientific’s FARAPULSE Gains FDA Approval for Expanded Use in Persistent Atrial Fibrillation
US-based Boston Scientific Corporation (NYSE: BSX) announced that it has received US FDA approval for...
Grand Pharma’s SIR-Spheres Y-90 Gets FDA Accelerated Approval for Unresectable HCC
China-based Grand Pharmaceutical Group Limited (HKG: 0512) announced that SIR-Spheres Y-90 resin microspheres (SIR-Spheres), a...
AstraZeneca’s Imfinzi Approved in EU for Perioperative Treatment of Muscle-Invasive Bladder Cancer
UK-based AstraZeneca (AZ, NASDAQ: AZN) announced that it has received marketing approval in the European...
Eli Lilly’s Mounjaro Approved by China’s NMPA for Obstructive Sleep Apnea in Obese Adults
US pharma giant Eli Lilly & Co. (NYSE: LLY) announced that it has received a...
Sino Biopharmaceutical’s Recombinant Factor VIIa N01 Approved by NMPA for Hemophilia Treatment
China’s Sino Biopharmaceutical Ltd (HKG: 1177) announced that it has received marketing approval from the...
Thermo Fisher’s Oncomine Dx Express Test Approved by FDA as Companion Diagnostic for Dizal’s Zegfrovy
US-based Thermo Fisher Scientific Inc. (NYSE: TMO) announced that it has received marketing approval from...
Jiangsu Hengrui Announces NMPA Approval for Miebo in Dry Eye Disease Treatment
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received marketing approval...
Hangzhou Jiuyuan Announces NMPA Approval for Generic Doptelet in Thrombocytopenia Treatmen
Hangzhou Jiuyuan Gene Engineering Co., Ltd. (HKG: 2566) announced that it has received marketing approval...
Betta Pharmaceuticals’ Kangmeina Approved by NMPA for Advanced Breast Cancer Treatment
China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) announced that it has received market approval from...
Regeneron’s Lynozyfic Granted FDA Accelerated Approval for Relapsed/Refractory Multiple Myeloma
US-based Regeneron Pharmaceuticals Inc., (NASDAQ: REGN) announced that it has received accelerated approval from the...
Sumitomo Pharma’s Xenleta Approved in China for Community-Acquired Pneumonia Treatment
Japan-based Sumitomo Pharma Co., Ltd announced that it has received market approval in China for...
BEBT-908 Receives Conditional NMPA Approval for Relapsed/Refractory DLBCL
Guangzhou BeBetter Medicine Technology Co., Ltd’s first-in-class HDAC/PI3Kα dual-targeted inhibitor BEBT-908 has received conditional approval...
Dizal’s Sunvozertinib Receives FDA Accelerated Approval for EGFR Exon20ins NSCLC
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) announced that the U.S. Food and Drug Administration...
Simcere Pharma’s Suvemcitug Approved by China’s NMPA for Platinum-Resistant Ovarian Cancer
China-based Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) announced that it has received marketing approval...
AbbVie’s Venclexta Approved by China’s NMPA for CLL/SLL Patients with 17p Deletion
US-based major AbbVie Inc., (NYSE: ABBV) announced that it has received marketing approval from China’s...
Changchun GeneScience’s Firsekibart Receives NMPA Approval for Acute Gouty Arthritis
China-based Changchun GeneScience Pharmaceutical Co., Ltd announced that it has received market approval for its...
Takeda Pharmaceutical Gains FDA Approval for Gammagard Liquid Erc in Primary Immunodeficiency
Japan-based Takeda Pharmaceutical (TYO: 4502, NYSE: TAK) announced that it has received marketing approval from...