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CSPC Pharmaceutical’s rhTNK-tPA Gets NMPA Approval for Acute Ischemic Stroke Treatment
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has approved a supplementary market approval filing for its recombinant human TNK tissue-type plasminogen activator for injection (rhTNK-tPA). The drug is now approved for use as a thrombolytic…
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Biotech Pharmaceutical Secures Approval for Nimotuzumab in Head and Neck Cancer Treatment
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Sino-Cuban joint venture Biotech Pharmaceutical Limited (BPL) has secured another indication approval in China for its biologic drug nimotuzumab, now authorized for the treatment of locally advanced head and neck squamous cell carcinoma (HNCC). Nimotuzumab, an EGFR monoclonal antibody (mAb), previously received marketing approvals in China for nasopharyngeal carcinoma (NPC)…
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Jiangsu Hengrui Receives Chinese Approval for First Domestic Category 1 Opioid Analgesic for Postoperative Pain
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has proclaimed the receipt of marketing approval in China for its proprietary drug, tegileridine, indicated for the management of moderate to severe pain following abdominal surgery. This milestone marks the drug as the nation’s inaugural Category 1 opioid analgesic developed indigenously, highlighting a…
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Acotec Scientific’s Peridge Catheter Receives NMPA Nod for Hemodialysis Lesion Treatment
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Acotec Scientific Holdings Ltd (HKG: 6669), a China-based medical device company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its innovative peripheral scoring balloon dilation catheter, Peridge. This device is designed for the treatment of occlusive lesions in autologous or synthetic arteriovenous…
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Gilead’s Kite Subsidiary Reduces CAR T-Cell Therapy Turnaround Time with FDA Approval
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Kite, a subsidiary of Gilead (NASDAQ: GILD), has announced a significant enhancement in the treatment process for its CAR T-cell therapy, Yescarta (axicabtagene ciloleucel). The median turnaround time (TAT) for this life-saving therapy is set to decrease from 16 days to 14 within the United States, following an approval by…
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Sandoz Launches Biosimilar Natalizumab in Germany, Challenging Biogen’s Tysabri
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Sandoz, a division of Novartis and a leader in generic drugs and biosimilars headquartered in Switzerland (SWX: SDZ), has announced the launch of Tyruko (natalizumab), the first biosimilar version of Biogen’s (NASDAQ: BIIB) blockbuster Tysabri, in the German market. This move marks a significant advancement in the treatment options for…
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European Commission Approves Takeda’s Hyqvia for Chronic Inflammatory Demyelinating Polyneuropathy
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The European Commission (EC) has granted regulatory approval to Takeda Pharmaceutical Company Limited (TYO: 4502) for its plasma-derived therapy Hyqvia (human immune globulin infusion 10% with recombinant human hyaluronidase) as a maintenance treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). This follows a similar indication extension for the subcutaneous drug in…
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Hengrui Pharmaceuticals Scores First-Mover Status with FDA Approval for Generic Astagraf XL
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its sustained-released generic version of Astagraf XL (tacrolimus), originally developed by Japan-based Astellas. With this…
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Takeda’s Gammagard Liquid Approved by FDA for Chronic Inflammatory Demyelinating Polyneuropathy
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The US Food and Drug Administration (FDA) has granted regulatory approval for Takeda’s (TYO: 4502) plasma-derived therapy Gammagard Liquid, a human immune globulin, for use as induction therapy and treatment for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. This decision is supported by clinical data demonstrating that the intravenous immunoglobulin…
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EMA’s CHMP Endorses Bristol Myers Squibb’s CAR-T Therapy Abecma for Multiple Myeloma
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has endorsed Bristol Myers Squibb’s (BMS; NYSE: BMY) CAR-T cell therapy, Abecma (idecabtagene vicleucel), for the treatment of relapsed and refractory multiple myeloma (r/r MM) in adults who have undergone at least two prior therapies.…
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Dupixent by Sanofi and Regeneron Approved by FDA for Eosinophilic Esophagitis in Younger Pediatric Patients
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The US Food and Drug Administration (FDA) has concluded a priority review and granted approval to Sanofi (NASDAQ: SNY) and Regeneron (NASDAQ: REGN) for their interleukin blocker Dupixent (dupilumab) as a treatment for eosinophilic esophagitis (EoE) in patients aged 1 to 11 years. This indication expansion makes Dupixent the sole…
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Eisai’s Alzheimer’s Drug Leqembi Earns Marketing Approval in China
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Eisai (TYO: 4523), a leading Japanese pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Leqembi (lecanemab), an amyloid-beta (Aβ)-targeting therapy indicated for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD). This…
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Gan & Lee Pharmaceuticals Receives Bolivian Approval for Insulin Aspart, Expanding Access to Rapid-Acting Insulin
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Gan & Lee Pharmaceuticals (SHA: 603087), a Chinese pharmaceutical company, has announced that it has received marketing approval from Bolivia’s Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED) for its Insulin Aspart (cartridge bottle). Insulin Aspart, a rapid-acting insulin analogue, begins to take effect within 10-20 minutes of subcutaneous…
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Pfizer’s Nurtec Approved by China’s NMPA for Acute Treatment of Migraines
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Pfizer Inc. (NYSE: PFE), a leading pharmaceutical company in the U.S., has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for Nurtec (rimegepant), indicated for the acute treatment of migraine with or without aura. Rimegepant, developed originally by Biohaven, is the first oral CGRP…
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Novo Nordisk’s Rybelsus Approved for Type 2 Diabetes in China, Setting New Oral Treatment Standard
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Novo Nordisk (NYSE: NVO), a major Danish pharmaceutical company, has received approval from China’s National Medical Products Administration (NMPA) for its drug Rybelsus (semaglutide) for the treatment of type 2 diabetes. The approval covers filing numbers JXSS2200016, JXSS2200017, and JXSS2200018. Rybelsus, recognized as the world’s first and currently only oral…
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Zylox-Tonbridge Medical Technology Secures NMPA Nod for Innovative Iliac Vein Stent System
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Zylox-Tonbridge Medical Technology (HKG: 2190), a leading developer of nerve and peripheral vascular interventional devices based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its ZYLOX Penguin iliac vein stent system. This innovative product is designed for the treatment of…
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Jiangsu Wuzhong Pharmaceutical’s Aesthetics Subsidiary Wins Approval for Facial Filler in China
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Jiangsu Wuzhong Pharmaceutical Group Corp., (SHA: 600200), a prominent player in the Chinese pharmaceutical industry, has announced that its medical aesthetics subsidiary’s polylactic acid facial filler, AestheFill, has received marketing approval in China. The product is slated to become available in mainland China in the first half of 2024. AestheFill,…
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Lepu Medical Technology Gains NMPA Approval for Innovative Coronary Device
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Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a leading Chinese provider of cardiovascular disease solutions, has received marketing approval from the National Medical Products Administration (NMPA) for its self-developed coronary mastoid balloon dilation catheter. The device, classified as a Category III medical device, is indicated for balloon dilation in…
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AstraZeneca Wins FDA Nod for Airsupra in Asthma Treatment
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AstraZeneca (AZ; NASDAQ: AZN), a leading UK pharmaceutical company, announced this week that it has received regulatory approval from the US Food and Drug Administration (FDA) for its respiratory drug Airsupra (albuterol + budesonide). The drug is now approved for the treatment or prevention of asthma symptoms and for the…
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NMPA Grants Marketing Approval for Hui Sheng Bio-pharmaceutical’s Janagliflozin
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The National Medical Products Administration (NMPA) has granted marketing approval for Hui Sheng Bio-pharmaceutical Co., Ltd’s Category 1 drug janagliflozin, which is indicated for the control of blood sugar levels in adults with type 2 diabetes. The drug can be used as a monotherapy or in combination with metformin. Janagliflozin,…
