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Fosun Pharmaceutical’s Daxxify Receives NMPA Approval for Cervical Muscle Tone Disorders
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has approved another indication for its product Daxxify (daxibotulinumtoxin, RT002). The type A botulinum toxin is now approved for the treatment of adult cervical muscle tone disorders in China. Background on…
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Genesis RMN Robotic Magnetic Navigation System Approved by China’s NMPA
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The Genesis RMN cardiac electrophysiological robot magnetic navigation system, represented in China by Shanghai Microport EP Medtech Co., Ltd, (SHA: 688351) has been granted marketing approval by the National Medical Products Administration (NMPA) in China. Global Recognition and Enhanced FeaturesDeveloped by Stereotaxis, the Genesis RMN system has already received approval…
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GSK plc Receives EC Approval for Single-Vial Menveo Vaccine for Meningococcal Disease
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GSK plc (NYSE: GSK) has announced that it has received marketing approval from the European Commission (EC) for its Menveo vaccine, a Meningococcal Group A, C, W-135, and Y conjugate vaccine (MenACWY vaccine), in a single-vial, fully liquid presentation. This formulation is designed for the prevention of invasive meningococcal disease…
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Thederma’s TAP-1503 Cream Approved by China’s NMPA for Atopic Dermatitis Treatment
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China-based Thederma has announced that its TAP-1503 cream has been granted approval by the National Medical Products Administration (NMPA) with priority review status. The drug, containing 1% tapinarof as a small molecule chemical drug, is now approved for the treatment of atopic dermatitis (eczema) in children over two years old…
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Novartis’s Kisqali Approved by EC for Adjuvant Treatment of High-Risk Early Breast Cancer
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Swiss pharmaceutical company Novartis (NYSE: NVS) has announced that it has received marketing approval from the European Commission (EC) for its CDK4/6 inhibitor Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early…
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Chia Tai Tianqing’s Benmelstobart Combo Approved by NMPA for Endometrial Cancer Treatment
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China-based Chia Tai Tianqing has announced that the National Medical Products Administration (NMPA) has granted another indication approval for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450). The drug is now approved in combination with the multi-target kinase inhibitor anlotinib to treat patients with non-Microsatellite Instability-High (non MSI-H)…
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Sichuan Kelun-Biotech’s SKB264/MK-2870 Approved by NMPA for Triple Negative Breast Cancer
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a China-based biopharmaceutical company, has received market approval from the National Medical Products Administration (NMPA) for its drug sacituzumab tirumotecan (SKB264/MK-2870). This drug is intended to treat adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have previously…
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CORXEL’s Varenicline Nasal Spray Approved by NMPA for Dry Eye Treatment
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Shanghai-based CORXEL, formerly known as Ji Xing Pharmaceuticals, supported by RTW Investments, has received approval from China’s National Medical Products Administration (NMPA) for its varenicline nasal spray, which is indicated for increasing tear secretion in patients diagnosed with xerophthalmia. Clinical Studies Support NMPA ApprovalThe NMPA’s approval was grounded in data…
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Zymeworks and Jazz Pharmaceuticals’ Ziihera Gets Green Light for HER2+ BTC Treatment
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Partners Zymeworks Inc. (NASDAQ: ZYME) and Jazz Pharmaceuticals, Inc. have received accelerated approval from the US Food and Drug Administration (FDA) for Ziihera (zanidatamab), a treatment for adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC). This marks a significant advancement in the treatment options for…
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Acotec Scientific Holdings Receives NMPA Approval for Thrombus Aspiration Catheter Support Tube
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its thrombus aspiration catheter special support tube. This product is designed to assist in the delivery and placement of interventional instruments during peripheral vascular intervention surgery. Enhancing…
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MicroPort Scientific Corp.’s BonaFire Receives NMPA Approval as First Whole-Body MRI Safety Pacing Electrode Lead
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Shanghai-based medical device giant MicroPort Scientific Corp. (HKG: 0853) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its whole-body magnetic resonance imaging (MRI) condition safety pacing electrode lead, BonaFire. This marks a significant milestone, as BonaFire becomes the first product of its…
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GSK’s Arexvy Receives MHLW Approval for Expanded RSV Indication in Japan
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UK-based pharmaceutical company GlaxoSmithKline (GSK; NYSE: GSK) has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved an expansion of the indication for Arexvy to include adults aged 50-59 who are at an increased risk of respiratory syncytial virus (RSV) infection. This marks a significant step in…
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Bayer’s Nubeqa Files for FDA Approval in mHSPC
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German pharmaceutical company Bayer AG (ETR: BAYN) has announced that the US Food and Drug Administration (FDA) has accepted its supplemental new drug application (sNDA) for Nubeqa (darolutamide) for review. Bayer is seeking approval for its androgen receptor inhibitor (ARi) in combination with androgen deprivation therapy (ADT) for the treatment…
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China Grants Marketing Approval for MSD’s Welireg for von Hippel-Lindau Disease Tumors
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China’s National Medical Products Administration has issued marketing approval for Merck, Sharp & Dohme’s (MSD; NYSE: MRK) oral drug Welireg (belzutifan) as a therapy for von Hippel-Lindau (VHL) disease-related renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastoma, and pancreatic neuroendocrine tumor (pNET) that do not require immediate surgical intervention.…
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Easton Pharmaceutical Secures NMPA Approval for Generic Jakavi and Urocit-K
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Chengdu-based Easton Pharmaceutical Co., Ltd (SHA: 688513) has announced that it has received separate marketing approvals from the National Medical Products Administration (NMPA) for its generic versions of Incyte Corporation’s Jakavi(ruxolitinib) and Missionpharma’s Urocit-K(potassium citrate), marking a significant milestone for the company. Approval of Generic JakaviJakavi, a JAK inhibitor, is…
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Medtronic Receives US Approval for InPen App with Missed Meal Dose Detection
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US-Irish firm Medtronic (NYSE: MDT) has announced US market approval for its new InPen app, which features missed meal dose detection. This innovation marks a significant step in the launch of Medtronic’s Smart MDI system, integrated with the Simplera continuous glucose monitor (CGM). InPen App: A Pioneer in Real-Time Insulin…
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NMPA Approves Alpha Biopharma’s Zorifertinib for First-Line NSCLC Treatment with CNS Metastases
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The National Medical Products Administration (NMPA) has granted approval to China-based Alpha Biopharma’s zorifertinib, commercially known as Zorifer, for the treatment of first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation and central nervous…
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Pfizer’s Hympavzi Receives European Commission Approval for Hemophilia A and B
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US pharmaceutical major Pfizer Inc. (NYSE: PFE) has announced that the European Commission (EC) has granted approval for its drug Hympavzi (marstacimab-hncq) for the routine prophylaxis of bleeding episodes in patients aged 12 years and older weighing at least 35 kg with severe hemophilia A (congenital factor VIII [FVIII] deficiency,…
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UCB’s Bimzelx Receives US FDA Approval for Moderate to Severe Hidradenitis Suppurativa
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Belgium-based biopharmaceutical company UCB (FRA: UNC) has announced that the US Food and Drug Administration (FDA) has granted another indication approval for its drug Bimzelx (bimekizumab), an interleukin 17A (IL-17A) and IL-17F targeted antibody. The FDA has approved Bimzelx for the treatment of adults with moderate to severe hidradenitis suppurativa…
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New Horizon Health Registers Three Medical Devices in Hong Kong’s Department of Health
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Hangzhou-based New Horizon Health Ltd (HKG: 6606) has announced the successful registration of three of its medical products with the Department of Health in the Hong Kong Special Administrative Region, facilitated through the Medical Device Administrative Control System (MDACS). This development marks a significant expansion of the company’s reach and…
