-
Boehringer Ingelheim and Eli Lilly’s Jardiance Approved by EC for Chronic Kidney Disease
•
Germany-based Boehringer Ingelheim and its US partner Eli Lilly & Co., (NYSE: LLY), have reported receiving European Commission (EC) approval for Jardiance (empagliflozin) as a treatment for adults with chronic kidney disease (CKD). This marks an expansion of Jardiance’s indications, which already include type 2 diabetes and heart failure. Expanding…
-
FDA Approves Daiichi Sankyo’s Vanflyta for FLT3-ITD Positive AML Maintenance Treatment
•
The US Food and Drug Administration (FDA) has granted clearance to Japan-based Daiichi Sankyo (TYO: 4568) for its type II FLT3 inhibitor, Vanflyta (quizartinib), as a maintenance treatment following consolidation chemotherapy for newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive in adult patients. Phase III Study Results and…
-
AbbVie’s Aquipta and Novartis’s Piqray Receive Regulatory Approvals in Mexico
•
Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS) has granted registration approvals to two innovative drugs: AbbVie’s (NYSE: ABBV) analgesic Aquipta (atogepant) and Novartis’ (NYSE: NVS) cancer therapy Piqray (alpelisib). This marks a significant milestone for both companies, expanding access to these treatments in the Mexican market. Aquipta: A…
-
Janssen’s Sirturo (Bedaquiline) Expands Indication to Include Adolescents with MDR-TB
•
The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has announced that the National Medical Products Administration (NMPA) has granted another indication approval for its medication Sirturo (bedaquiline). The product is now approved for the treatment of adolescents aged 12-18 years and weighing ≥30kg with multidrug-resistant pulmonary tuberculosis (MDR-TB),…
-
Sanofi and AstraZeneca Receive FDA Approval for RSV Prevention Treatment Beyfortus
•
France-based Sanofi (NASDAQ: SNY) has announced that it, along with AstraZeneca (AZ; NASDAQ: AZN), has received marketing approval from the US Food and Drug Administration (FDA) for their codeveloped drug, Beyfortus (nirsevimab). The drug is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in…
-
Antengene Corp., Ltd Receives Hong Kong NDA Approval for Xpovio in Relapsed Multiple Myeloma
•
China-based biopharmaceutical company Antengene Corp., Ltd (HKG: 6996) has announced receiving New Drug Application (NDA) approval from the Department of Health of Hong Kong. The approval is for the use of Xpovio in adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior…
-
GSK’s Cabotegravir Receives NMPA Approval for HIV Treatment in China
•
The National Medical Products Administration (NMPA) has granted marketing approval for GlaxoSmithKline’s (GSK, NYSE: GSK) cabotegravir, a significant development in HIV treatment options. Both the injection and tablet dosage forms of the drug have been approved for use in China. Cabotegravir: An Innovative INSTI for HIV TreatmentCabotegravir is an integrase…
-
Beijing Tinavi Medical’s Knee Replacement Navigation System Approved by NMPA
•
Beijing Tinavi Medical Technologies Co., Ltd (SHA: 688277) has received marketing approval from the National Medical Products Administration (NMPA) for its innovative navigation and positioning system designed for knee joint replacement surgery. This marks the 218th innovative product designation granted by China’s NMPA. Innovative 6-DOF Robotic Arm Technology in Knee…
-
Sino Medical Sciences Receives Approval for Next-Generation Drug-Eluting Stent in Indonesia
•
China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced receiving market approval for its next-generation drug-eluting stent system, BuMA Supreme, in Indonesia. The product is approved for use in improving the symptoms of vascular stenosis and will be eligible for marketing until October 19, 2027. Composition and Design of…
-
Peijia Medical Receives NMPA Approval for DCwire Micro Guide Wire Device in China
•
Peijia Medical Ltd (HKG: 9996), a leading Chinese firm in the neurointerventional field, has announced receiving market approval from the National Medical Products Administration (NMPA) in China for its DCwire micro guide wire device. This milestone marks the company’s 15th neurointerventional product approval in China, highlighting its commitment to advancing…
-
3SBio Inc. Receives NMPA Approval for Nalfurafine Tablets to Treat Hemodialysis-Related Pruritus
•
China-based 3SBio Inc. (HKG: 1530) has announced receiving marketing approval from the National Medical Products Administration (NMPA) in China for its nalfurafine orally disintegrating tablets. The drug is used to improve pruritus in hemodialysis patients in situations where existing treatment efficacy is not ideal. This marks the first and only…
-
AbbVie’s Rinvoq Receives NMPA Approval for Moderate to Severe Crohn’s Disease Treatment
•
US pharmaceutical firm AbbVie (NYSE: ABBV) has announced receiving market approval from the National Medical Products Administration (NMPA) for its Rinvoq (upadacitinib), a selective JAK inhibitor, to treat moderate to severe active Crohn’s disease in adult patients who have a poor or intolerant response or a contraindication to one or…
-
Luye Pharma’s Goserelin Acetate Microspheres Approved by NMPA for Prostate Cancer Treatment
•
Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its injectable goserelin acetate in microsphere form, a treatment for prostate cancer requiring androgen castration therapy. This innovative formulation is designed to provide a smoother drug release during the…
-
Huadong Medicine’s Liraglutide Biosimilar Gains NMPA Approval for Weight Loss Indication
•
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received additional indication approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novo Nordisk’s (NYSE: NVO) Victoza (liraglutide). This glucagon-like peptide-1 (GLP-1) receptor agonist is now approved for use in weight loss management. Expanding…
-
NMPA Approves Pitolisant for Narcolepsy-Related Excessive Daytime Drowsiness and Cataplexy
•
The National Medical Products Administration (NMPA) has approved pitolisant as a treatment for excessive daytime drowsiness (EDS) or cataplexy in adults with narcolepsy. This marks a significant advancement in the therapeutic options available for narcolepsy patients in China. Pitolisant’s Mechanism of Action and International DesignationsPitolisant is a selective histamine 3…
-
Innovent Biologics and IASO Biotherapeutics’ Fucaso Approved for Multiple Myeloma Treatment in China
•
Innovent Biologics, Inc. (HKG: 1801) and IASO Biotherapeutics have announced that they have received marketing approval from the National Medical Products Administration (NMPA) for their jointly developed and commercialized product, Fucaso (equecabtagene autoleucel). This approval positions Fucaso as the first fully-human BCMA-directed chimeric antigen receptor (CAR) T cell therapy approved…
-
Zai Lab’s Vyvgart Receives NMPA Approval as First-in-Class FcRn Antagonist for Myasthenia Gravis
•
Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a China-based biopharmaceutical company, has announced that the National Medical Products Administration (NMPA) has approved its Biologics License Application (BLA) for Vyvgart (efgartigimod alfa injection). Vyvgart, a first-in-class neonatal Fc receptor (FcRn) antagonist, is now approved for use as an add-on to standard…
-
Hansoh Pharmaceutical’s Phenylheptal Peptide Receives NMPA Approval for Anemia Treatment
•
The National Medical Products Administration (NMPA) has issued a marketing approval for China-based Hansoh Pharmaceutical Group Co., Ltd’s (HKG: 3692) Category 1 product, phenylheptal peptide. This drug is indicated for the treatment of anemia in adult non-dialysis patients who are not receiving erythropoiesis stimulator (ESA) treatment, and in adult dialysis…
-
Sinocelltech Group Receives NMPA Approval for Bevacizumab Biosimilar for Multiple Cancers
•
China-based Sinocelltech Group Ltd (SHA: 688520) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its bevacizumab biosimilar. This biosimilar will be used to treat a range of cancers including metastatic colorectal cancer (CRC), recurrent glioblastoma, advanced metastatic or recurrent non-small cell lung…
