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MSD’s Keytruda Secures FDA Approval for Advanced or Recurrent Endometrial Carcinoma
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that the U.S. Food and Drug Administration (FDA) has granted an additional indication for its programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab). The drug is now approved for use in combination with chemotherapy for adults with primary advanced or recurrent endometrial carcinoma,…
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FDA Approves Broadened Use of BMS’ Next-Gen TKI Augtyro for Advanced Solid Tumors
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an accelerated approval for its next-generation tyrosine kinase inhibitor (TKI), Augtyro (repotrectinib), for the treatment of locally advanced, metastatic, or unresectable NTRK fusion-positive solid tumors. This decision follows the drug’s progression after treatment or in…
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AstraZeneca’s Farxiga Receives FDA Approval for Pediatric Type-2 Diabetes Treatment
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The US Food and Drug Administration (FDA) has granted regulatory approval to AstraZeneca (AZ; NASDAQ: AZN) for its SGLT2 inhibitor, Farxiga (dapagliflozin), expanding its use to pediatric patients aged 10 and above with type-2 diabetes (T2D). This approval supplements the drug’s original indication for adult patients. The FDA’s decision was…
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Amgen’s Prolia Secures NMPA Approval for Treating Glucocorticoid-Induced Osteoporosis in High-Risk Patients
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Biopharmaceutical giant Amgen has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug Prolia (denosumab) to treat glucocorticoid-induced osteoporosis (GIOP) in patients at high risk of fractures. This approval marks a significant expansion of Prolia’s indication in China, where it is already approved to treat osteoporosis…
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Eli Lilly’s Baqsimi Gains NMPA Approval for Diabetes Hypoglycemia Treatment
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The National Medical Products Administration (NMPA) in China has granted approval to Eli Lilly & Co. (NYSE: LLY) for its Baqsimi (glucagon nasal powder spray), marking a significant advancement in the treatment of severe hypoglycemia in diabetic patients aged four and above. Hypoglycemia, a common and potentially dangerous complication of…
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Joincare Pharmaceutical Receives NMPA Approval for Generic Seretide
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Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380), a leading pharmaceutical company based in China, has announced that it has obtained marketing approval from the National Medical Products Administration (NMPA) for its generic version of GlaxoSmithKline’s (GSK) Seretide (salmeterol, fluticasone). This compound inhalable preparation is now approved for use as…
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Accuray Wins Chinese Nod for Precision Treatment Planning System, Boosting Regional Expansion
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U.S. medical device company Accuray Inc. (NASDAQ: ARAY) has announced that it has received market approval from Chinese regulatory authorities for its Accuray Precision Treatment Planning System (TPS). This approval will enable the integration of the TPS with the Tomo C radiation therapy system, which is part of the CNNC-Array…
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Junshi Biosciences’ Toripalimab Scores New Indication for First-Line ES-SCLC Treatment in China
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced an expansion of indications for its immunotherapy drug Loqtorzi (toripalimab) following approval from China’s National Medical Products Administration (NMPA). The programmed death-1 (PD-1) inhibitor is now approved for use in combination with chemotherapy for the first-line treatment of patients…
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Kyowa Kirin’s Evocalcet Wins NMPA Nod for Chronic Kidney Disease Treatment
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Kyowa Kirin Co. (TYO: 4151), a Japanese pharmaceutical firm, has secured marketing approval from China’s National Medical Products Administration (NMPA) for its novel drug evocalcet. The drug is indicated for the treatment of secondary hyperparathyroidism (SHPT) in patients undergoing maintenance dialysis due to chronic kidney disease (CKD). Evocalcet, classified as…
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Luye Pharma’s Paliperidone Palmitate Injection Wins NMPA Nod for Schizophrenia Treatment
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Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its paliperidone palmitate injection. This second-generation antipsychotic long-acting injection is now approved for the treatment of schizophrenia during both the acute and…
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Sansure Biotech’s Tuberculosis Detection Kit Gains CE IVDR Certification for EU Market
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Sansure Biotech Inc. (SHA: 688289), a leading molecular diagnostics company based in China, has announced that it has received CE IVDR certification from the European Union for its mycobacterium tuberculosis nucleic acid detection kit, which utilizes the PCR fluorescence probe method. This certification marks a significant milestone, as it grants…
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Novartis’s Tabrecta Earns NMPA Nod for MET-Positive Advanced NSCLC in China
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Swiss pharmaceutical titan Novartis has secured marketing approval from China’s National Medical Products Administration (NMPA) for its drug Tabrecta (capmatinib), intended for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a mesenchymal–epithelial transition (MET) exon 14 skipping mutation, who have not received…
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MicroPort Endovascular MedTech Secures NMPA Approval for Vena Cava Filter
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a prominent medical device company based in China, has announced that it has received a Category III medical device license from the National Medical Products Administration (NMPA) for its newly developed vena cava filter. This device is designed to be percutaneously inserted…
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Qilu Pharmaceutical’s Generic Pomalidomide Wins NMPA Nod for Multiple Myeloma Treatment
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Qilu Pharmaceutical, a leading pharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) for its generic version of Celgene’s pomalidomide, expanding treatment options for multiple myeloma patients in China. This drug, a derivative of the immunomodulator thalidomide, is recognized for its anti-tumor efficacy. It…
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Rightongene Bio Receives NMPA Approval for BCR-ABL P210 Fusion Gene Detection Kit
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Shanghai Rightongene Biotechnology Co., Ltd (SHA: 688217), a biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its BCR-ABL P210 fusion gene detection kit, which uses the fluorescence reverse transcription polymerase chain reaction (RT-PCR) method. The kit is…
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Zylox-Tonbridge Medical Technology Earns NMPA Approval for First Vascular Stapler in China
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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 proprietary ZYLOX Unicorn vascular stapler, marking the first approval of its kind in China. The…
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Allergan Aesthetics’ Botox Secures New Indication for Masseter Muscle Protrusion in China
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Allergan Aesthetics, a division of AbbVie (NYSE: ABBV), has announced that it has received approval for a new indication from the National Medical Products Administration (NMPA) for its Botox (botulinum toxin type A) product. The drug is now approved for the temporary improvement of significant or very significant masseter muscle…
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Varian Medical Gets China Approval for Fourth-Generation Halcyon Radiotherapy System
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Varian Medical Systems (NYSE: VAR), a US-based leader in cancer treatment technology, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its fourth-generation Halcyon radiotherapy platform. The Halcyon system is a circular rack radiotherapy platform designed to deliver efficient image-guided automated radiation therapy.-…
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CSPC Pharmaceutical Secures NMPA Nod for Generic Version of AstraZeneca’s Lynparza
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of AstraZeneca’s PARP inhibitor Lynparza (olaparib). This marks CSPC Pharmaceutical’s entry into the segment with the third generic…
