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Walvax Biotechnology Secures BPOM Approval for Weuphoria Pneumococcal Vaccine
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced that it has received market approval from the Indonesian Food and Drug Control Agency (BPOM) for its Weuphoria, a 13-valent pneumococcal polysaccharide conjugate vaccine (PCV-13). This approval is a significant milestone for Walvax as it expands its reach into the Indonesian…
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Pfizer’s Penbraya Receives FDA Approval for Meningococcal Immunization
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Pfizer Inc. (NYSE: PFE) announced last week that it has successfully registered its pentavalent meningococcal vaccine, Penbraya, with the US Food and Drug Administration (FDA). The vaccine is designed for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals aged…
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Health Canada Approves Pfizer and Sumitomo Pharma’s Myfembree for Endometriosis Pain Management
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Health Canada has granted regulatory approval to Pfizer (NYSE: PFE) and Sumitomo Pharma (TYO: 4506) for their women’s health product Myfembree (relugolix + estradiol + norethindrone acetate). The approval is for the management of moderate-to-severe pain associated with endometriosis in pre-menopausal women, supported by late-stage data from multiple trials. Previous…
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BMS’s Sotyktu Receives NMPA Approval for Psoriasis Treatment
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The National Medical Products Administration (NMPA) has granted regulatory approval to US-based pharmaceutical major Bristol-Myers Squibb (BMS, NYSE: BMY) for its first-in-class selective tyrosine kinase 2 (TYK2) inhibitor, Sotyktu (deucravacitinib). The drug is indicated for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Mechanism of…
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AstraZeneca’s Soliris Gains Approval in China for NMOSD Treatment
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UK-based pharmaceutical giant AstraZeneca Plc (AZ, NASDAQ: AZN) has announced that its rare disease drug Soliris (eculizumab) has received marketing approval in China for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in AQP4 antibody positive (Ab+) adults. This approval marks a significant expansion of Soliris’s application in the Chinese…
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Lepu Medical Gains NMPA Approval for Semi-Automatic External Defibrillator
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China-based cardiovascular disease solutions provider Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its in-house developed semi-automatic external defibrillator. This approval marks a significant milestone in expanding Lepu’s portfolio of life-saving medical devices. The…
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Pfizer’s Velsipity Approved by FDA for Ulcerative Colitis Treatment
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China-based pharmaceutical company Everest Medicines (HKG: 1952) announced that its licensing partner, Pfizer Inc. (NYSE: PFE), has secured market approval from the US FDA for Velsipity (etrasimod). This oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator is indicated for adults with moderately to severely active ulcerative colitis (UC), marking a significant…
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FDA Approves Pfizer’s Braftovi + Mektovi Combo for BRAF V600E Metastatic NSCLC
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The US Food and Drug Administration (FDA) has granted Pfizer (NYSE: PFE) regulatory approval for the combination therapy of Braftovi (encorafenib) and Mektovi (binimetinib) for the treatment of metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. This decision is supported by interim results from an ongoing Phase…
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Nanjing Geneseeq’s NSCLC TMB Detection Kit Approved by NMPA
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China-based Nanjing Geneseeq Medical Device and Diagnostic Inc. has announced that its tissue tumor mutation burden (TMB) detection kit, utilizing a reversible end termination sequencing method, has received marketing approval from the National Medical Products Administration (NMPA). This marks the kit as the 231st novel medical device approved in China.…
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Betta Pharmaceuticals Secures NMPA Approval for Befotertinib in NSCLC Treatment
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China-based Betta Pharmaceuticals Co., Ltd. (SHE: 300558) has officially announced its receipt of market approval from the National Medical Products Administration (NMPA) for befotertinib, a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). This critical approval allows befotertinib to be used as a first-line treatment for locally advanced or…
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Jiangsu BioPerfectus Secures NMPA Approval for Norovirus Nucleic Acid Detection Kit
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China-based Jiangsu BioPerfectus Technologies Co., Ltd (SHA: 688399), a leading manufacturer of in vitro diagnostic (IVD) products, has announced that it has received medical device approval from the National Medical Products Administration (NMPA) for its Norovirus nucleic acid detection kit, utilizing the fluorescence PCR method. Innovative Detection of Norovirus The…
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Cochlear’s Artificial Cochlear Sound Processor Gains NMPA Approval for Marketing in China
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Australia-based Cochlear has received marketing approval from the National Medical Products Administration (NMPA) for its artificial cochlear sound processor, as announced by the Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration. This innovative product is designed to convert received sounds and transmit electrical stimulation to the auditory nerve through…
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Med Vision’s Sleep Disorder Software Receives Category II Approval in China
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Hangzhou-based Med Vision, a provider of virtual reality (VR)-enabled digital therapeutics (DTx) solutions, has reportedly received a Category II medical device approval in China for its sleep disorder assisted treatment software. This marks a significant milestone as it is the first VR-based sleep disorder device to be approved both in…
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Bio-Thera Solutions’ BAT1806 Receives US FDA Approval as Biosimilar to Actemra/RoActemra
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Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, announced that its biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab), known as BAT1806, has passed review by the US FDA. This milestone marks the approval of BAT1806 for use in the US market to treat a range of…
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Sanofi’s Nexviazyme Approved in China as Enzyme Replacement Therapy for Pompe Disease
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Sanofi’s (NASDAQ: SNY) next-generation enzyme replacement therapy (ERT), Nexviazyme (avalglucosidase alfa), has received marketing approval from the National Medical Products Administration (NMPA) as a long-term treatment for Pompe disease. This marks Sanofi’s second drug approved for Pompe disease in China, following the approval of Myozyme (alglucosidase alfa) in October 2015.…
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Amicus Therapeutics Secures FDA Approval for Pombiliti and Opfolda Combination Therapy
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Amicus Therapeutics (NASDAQ: FOLD), headquartered in the United States, has announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for its combination therapy of Pombiliti (cipaglucosidase alfa-atga) and Opfolda (miglustat) 65 mg capsules. This innovative two-component therapy is specifically indicated for adults diagnosed with…
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Takeda Receives FDA Approval for Subcutaneous Entyvio as UC Maintenance Therapy
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The US Food and Drug Administration (FDA) has granted Japan’s Takeda Pharmaceuticals (TYO: 4502) regulatory approval for the subcutaneous version of its alpha4beta7 integrin inhibitor, Entyvio (vedolizumab), as a maintenance therapy for adults with moderately to severely active ulcerative colitis (UC) following induction therapy with intravenous Entyvio. This decision comes…
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Neusoft Medical’s NeuRT Aurora Receives NMPA Approval for Advanced Radiotherapy Platform
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Neusoft Medical Systems Co., Ltd, a leading player in the medical technology sector, has announced that its radiotherapy unit, Neusoft Ruizhi Radiotherapy Technology Co., Ltd, has received marketing approval from the National Medical Products Administration (NMPA) for the high-end medical linear accelerator, NeuRT Aurora intelligent radiotherapy platform. This approval marks…
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CStone Pharmaceuticals’ PDGFRA Mutation Detection Kit Receives NMPA Approval
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CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its “Human PDGFRA Gene D842V Mutation Detection Kit”. This companion diagnostic (CDx) kit, co-developed with Beijing-based Genetron Holdings Ltd (Nasdaq: GTH), is used for the detection…
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Eli Lilly’s Insulin Biosimilar YouBiAn Approved for Diabetes Treatment in China
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US pharmaceutical major Eli Lilly (NYSE: LLY) has announced that it has received market approval from the National Medical Products Administration in China for its insulin glargine product, YouBiAn. This treatment is indicated for adults with type 1 or type 2 diabetes requiring insulin therapy, as well as for children…
