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Biogen and Samsung Bioepis Win EC Approval for Opuviz Biosimilar in Europe
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US-based Biogen Inc. (NASDAQ: BIIB) and South Korea’s Samsung Bioepis Co., Ltd. have jointly announced that they have received marketing approval from the European Commission (EC) for their Opuviz 40 mg/mL solution for injection in a vial. This biosimilar product, a version of Bayer/Regeneron’s Eylea (aflibercept), is now approved for…
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AbbVie’s Elahere Receives EC Approval for FRα-Positive Ovarian Cancer Treatment
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US-based AbbVie (NYSE: ABBV) has announced the European Commission (EC) approval for its antibody drug conjugate (ADC) Elahere (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. This approval marks Elahere as the first and…
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Everest Medicines’ Nefecon Receives Full Approval from South Korea’s MFDS for IgAN Treatment
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China-based Everest Medicines (HKG: 1952) has announced that it has received full approval from the Ministry of Food and Drug Safety (MFDS) in South Korea for its Nefecon (targeted-release budesonide) for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) who have a urine protein excretion of ≥1.0 g/day…
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Sandoz Receives EC Approval for Biosimilar to Eylea for Retinal Diseases
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Switzerland-based pharmaceutical company Sandoz (SWX: SDZ) has announced that it has received marketing approval from the European Commission (EC) for its biosimilar of Bayer/Regeneron’s (ETR: BAYN / NASDAQ: REGN) Eylea (aflibercept). The product is now available in the form of a 2 mg vial kit and pre-filled syringe for intravitreal…
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Shanghai Junshi Biosciences’ Toripalimab Wins UK Approval for Nasopharyngeal and Oesophageal Cancers
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced that it has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its PD-1 inhibitor, toripalimab, marketed as Loqtorzi. This approval allows the use of toripalimab in…
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GE Healthcare’s SIGNA MAGNUS MRI Scanner Receives FDA 510(k) Clearance
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US medical device and life sciences leader GE Healthcare Technologies Inc. (NASDAQ: GEHC) has announced the receipt of FDA 510(k) clearance for its innovative SIGNA MAGNUS, a 3.0T high-performance, head-only magnetic resonance imaging (MRI) scanner. This clearance marks a significant advancement in medical imaging technology, offering new capabilities for the…
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Zai Lab and argenx Receive NMPA Approval for Vygart Hytrulo in Chronic Inflammatory Demyelinating Polyneuropathy
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) and its US partner argenx SE (NASDAQ: ARGX) have announced the receipt of supplementary Biologic License Application (sBLA) approval from the National Medical Products Administration (NMPA) for Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). This approval allows Vygart Hytrulo to be…
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Cutia Therapeutics’ CU-10201 Receives NMPA Approval for Acne Vulgaris Treatment
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Cutia Therapeutics (HKG: 2487), a developer of dermatology therapies, has announced that its CU-10201, a 4% minocycline foam agent for external use, has received market approval from the National Medical Products Administration (NMPA) in China. The approval is for the treatment of non-nodular moderate to severe acne vulgaris in individuals…
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Sino Medical Sciences Technology Secures Marketing Approval in Peru for HT Supreme Stent System
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Sino Medical Sciences Technology Inc., (SHA: 688108), a leading Chinese medical technology company, has announced that it has received marketing approval in Peru for its HT Supreme drug-eluting stent system. This approval allows the use of the system to improve the diameter of the coronary artery lumen in symptomatic heart…
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Sino Biopharmaceutical Ltd Receives NMPA Approval for KRAS G12C Inhibitor Garsorasib
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company in China, has announced that it has received conditional marketing approval from the National Medical Products Administration (NMPA) for garsorasib (D-1553), a KRAS G12C inhibitor co-developed with InventisBio (Shanghai) Co., Ltd. The drug is indicated for the treatment of patients with…
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Johnson & Johnson MedTech’s Varipulse Platform Receives FDA Approval for Atrial Fibrillation Treatment
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Johnson & Johnson MedTech (J&J, NYSE: JNJ) has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Varipulse platform, marking a significant advancement in the treatment of drug refractory paroxysmal atrial fibrillation (AFib). The Varipulse platform is the company’s first pulsed field…
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Bayer AG Receives FDA 510(k) Clearance for MEDRAD Centargo CT Injection System
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Germany-based Bayer AG (ETR: BAYN) has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its MEDRAD Centargo CT Injection System. This innovative multi-patient injector is designed to enhance workflow efficiency and integrates seamlessly with Bayer’s existing portfolio of products, particularly in high-volume…
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Pfizer’s Talzenna (talazoparib) Approved by China’s NMPA for mCRPC Treatment
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The National Medical Products Administration (NMPA) website has indicated that Pfizer’s (NYSE: PFE) marketing filing for Talzenna (talazoparib) has been approved, clearing the way for the poly ADP-ribose polymerase (PARP) inhibitor to treat metastatic castration-resistant prostate cancer (mCRPC) in China. Talazoparib’s Global Approvals and IndicationsTalazoparib received approval in the US…
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Sanofi’s Dupixent Gains EMA Approval for Eosinophilic Esophagitis in Children
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that it has received marketing approval from the European Medicines Agency (EMA) for its drug Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children aged one to 11 years who weigh at least 15 kg. The approval covers patients who are inadequately…
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Amgen’s Tavneos Receives NMPA Approval for ANCA-Associated Vasculitis Treatment in China
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US biotechnology company Amgen (NASDAQ: AMGN) has announced that it has received market approval in China for its drug Tavneos (avacopan). The National Medical Products Administration (NMPA) has approved Tavneos for use as adjuvant therapy in adults with severe and active anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis, specifically granulomatous polyangitis…
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Changchun High & New Technology Industries Receives NMPA Approval for Long-Acting Somatropin
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Changchun High & New Technology Industries (Group) Inc., (SHE: 000661), a leading China-based company, has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its polyethylene glycol recombinant human somatropin, a long-acting somatropin, for the treatment of idiopathic short stature (ISS). Understanding Idiopathic…
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Huadong Medicine Co., Ltd Receives NMPA Approval for Stelara Biosimilar SaiLeXin
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Huadong Medicine Co., Ltd (SHE: 000963), a China-based pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) auto-immune disease drug Stelara (ustekinumab), named SaiLeXin. This development marks a significant step forward…
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China Medical System’s Opzelura Approved in Hong Kong for Non-segmental Vitiligo Treatment
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China Medical System Holdings (CMS; HKG: 0867) has announced that the market filing for its Opzelura (ruxolitinib) cream has been approved in Hong Kong. This topical Janus kinase (JAK) inhibitor is now approved for use as a local treatment for non-segmental vitiligo in patients aged 12 years and above, expanding…
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Asieris Pharmaceuticals Receives NMPA Approval for Hexvix (APL-1706) in Bladder Cancer Diagnosis
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China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has announced that the National Medical Products Administration (NMPA) has approved a marketing filing for its product Hexvix (APL-1706), which is used in the diagnosis and management of bladder cancer. Product Approval and ImpactThe approval of Hexvix by the NMPA marks a…
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BMS’s Opdivo Secures NMPA Approval for Urothelial Carcinoma Treatment
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its anti-PD-1 drug Opdivo (nivolumab) in combination with cisplatin and gemcitabine. This approval is for a first-line treatment of unresectable or metastatic urothelial carcinoma (UC). The Opdivo/chemo…
