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Sino Biopharmaceutical’s Tulobuterol Patch Gains NMPA Approval
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that its subsidiary Beijing Tide Pharmaceutical Co., Ltd has received marketing approval from the National Medical Products Administration (NMPA) for its tulobuterol patch. This marks the first approval of its kind domestically in China for a transdermal patch designed to relieve respiratory distress…
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Roche’s Susvimo Approved by FDA for Diabetic Macular Edema
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Swiss pharmaceutical giant Roche (SWX: ROG) announced that it has received approval from the US Food and Drug Administration (FDA) for another indication of its Susvimo (ranibizumab) 100 mg/mL, this time to treat diabetic macular edema (DME). With this approval, Susvimo becomes the first and only FDA-approved treatment shown to…
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FDA Approves Enhertu for HER2-Low and HER2-UltraLow Breast Cancer
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The US Food and Drug Administration (FDA) has approved Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow…
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Sino Medical Sciences’ NC Rockstar Catheter Gains MDA Approval in Malaysia
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China-based Sino Medical Sciences Technology Inc. (SHA: 688108) announced that it has received marketing approval from the Medical Device Authority (MDA) of Malaysia for its NC Rockstar non-compliant coronary artery balloon dilation catheter. The device is designed for balloon catheter dilation of autologous coronary artery or bypass stenosis to improve…
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Enhertu Approved by FDA for HR-Positive, HER2-Low Breast Cancer
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Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) jointly announced that their co-developed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received FDA approval for the treatment of unresectable or metastatic hormone receptor (HR) positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2 ultra-low (IHC 0 with membrane staining) breast…
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MicroPort’s Fireliums Receives NMPA Approval for Coronary Bifurcation Stenosis Treatment
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Shanghai-based medical device giant MicroPort Scientific Corp. (HKG: 0853) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its coronary rapamycin drug balloon dilation catheter, Fireliums, for dilation treatment of primary coronary artery bifurcation stenosis. This approval marks a significant milestone in the commercialization of this…
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MicroPort’s TomaHawk Intravascular Shock Wave Therapy Device Approved by NMPA
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Shanghai-based medical device giant MicroPort Scientific Corp. (HKG: 0853) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its TomaHawk intravascular shock wave therapy device, disposable coronary intravascular shock wave catheter (TomaHawk coronary intravascular shock wave catheter system). This approval marks a significant milestone in the…
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FDA Clears sBLA for Eisai and Biogen’s Leqembi Maintenance Dosing
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Partners Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have announced that the US Food and Drug Administration (FDA) has cleared their supplemental Biologics License Application (sBLA) for once every four weeks Leqembi (lecanemab-irmb) intravenous (IV) maintenance dosing. The drug is approved in the US for the treatment…
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Guangzhou Innogen’s Efsubaglutide Alfa Approved by NMPA for Type 2 Diabetes
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China-based Guangzhou Innogen Pharmaceutical Group Co., Ltd, a biopharma focused on metabolic diseases, has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its efsubaglutide alfa to treat type 2 diabetes (T2D). This approval marks a significant milestone in the development and commercialization of efsubaglutide alfa, positioning…
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Roche’s cobas liat STI Assay Panels Gain FDA Approval and CLIA Waiver
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced receiving approval from the US Food and Drug Administration (FDA) and a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas liat sexually transmitted infection (STI) multiplex assay panels. This marks a significant advancement in rapid diagnostic capabilities…
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Sanofi’s Sarclisa Approved in EU for Newly Diagnosed Multiple Myeloma
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France-based Sanofi (EPA: SAN, NASDAQ: SNY) has announced receiving marketing approval in the European Union (EU) for its CD38 monoclonal antibody (mAb) Sarclisa (isatuximab) in combination with the standard-of-care regimen of bortezomib, lenalidomide, and dexamethasone (VRd). The approval is for the treatment of adult patients with newly diagnosed multiple myeloma…
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Johnson & Johnson’s Spravato Approved as Monotherapy for Major Depressive Disorder
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US-based Johnson & Johnson (J&J; NYSE: JNJ) has announced that its Spravato (esketamine) CIII nasal spray has received clearance from the US Food and Drug Administration (FDA) as the first and only monotherapy for adults with major depressive disorder (MDD) who have had an inadequate response to at least two…
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Kehua Bioengineering Gains NMPA Approval for Gene Polymorphism Detection Kits
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China-based Shanghai Kehua Bioengineering Co., Ltd (SHE: 002022) has announced receiving marketing approvals from the National Medical Products Administration (NMPA) for its human CYP2C9 gene polymorphism detection kit and human VKORC1 gene polymorphism detection kit, both utilizing the fluorescence PCR method. These approvals mark a significant advancement in personalized medicine,…
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Acotec’s Vericor-S2 Coronary Microcatheter Approved by NMPA
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Acotec Scientific Holdings Ltd (HKG: 6669) has announced that its Vericor-S2 coronary microcatheter has received registration approval from the National Medical Products Administration (NMPA). The product is designed for use in percutaneous coronary interventions, specifically for guiding guidewires through narrow vessel lesions and providing a channel for saline or contrast…
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NMPA Approves Synaptic Medical’s Cryoablation Device and Gene Methylation Detection Kit
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China’s National Medical Products Administration (NMPA) has granted marketing approval for two new medical devices: Synaptic Medical’s cryoablation device and Wuhan Kadwise Biotechnology Co., Ltd’s human CDO1/AJAP1/GALR1 gene methylation detection kit (fluorescence PCR method). These approvals highlight advancements in treating atrial fibrillation and diagnosing endometrial cancer. Cryoablation Device for Atrial…
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GSK’s Jemperli Approved for First-Line Endometrial Cancer Treatment in EU
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UK-based GSK plc (NYSE: GSK, LON: GSK) has announced receiving approval from the European Commission for a new indication for its PD-1-blocking antibody Jemperli (dostarlimab). The drug is now approved for use in combination with chemotherapy (carboplatin and paclitaxel) as a first-line treatment for adult patients with primary advanced or…
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Kelun-Biotech’s Tagitanlimab Receives NMPA Clearance for Nasopharyngeal Carcinoma
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced receiving another clearance from the National Medical Products Administration (NMPA) for its PD-L1 monoclonal antibody (mAb) Ketailai (tagitanlimab). The latest approval indicates the drug for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) when combined with chemotherapy. This follows…
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Chongqing Genrix’s Xeligekimab Approved for Ankylosing Spondylitis by NMPA
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China-based Chongqing Genrix Bio Pharmaceutical Co., Ltd (SHA: 688443) has announced receiving approval from the National Medical Products Administration (NMPA) for an additional indication of its in-house developed Category 1 biologic product, xeligekimab. The anti-IL-17 antibody is now approved to treat ankylosing spondylitis (radiologically positive axial spondyloarthritis), following its initial…
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FDA Approves AstraZeneca’s Calquence for Mantle Cell Lymphoma
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UK-based pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) last week revealed that the US Food and Drug Administration (FDA) has approved its BTK inhibitor Calquence (acalabrutinib) in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic…
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MHRA Approves Gilead’s Livdelzi for Primary Biliary Cholangitis
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The Medicines and Healthcare products Regulatory Agency (MHRA) last week signed off on US-based Gilead Sciences Inc.’s (NASDAQ: GILD) Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC), including pruritus. This approval marks a significant step forward in the treatment options available for patients suffering from this chronic liver…
