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FDA Rejects MSD’s Gefapixant for Chronic Cough Treatment Over Efficacy Concerns
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The US Food and Drug Administration (FDA) has declined to approve a filing from Merck, Sharp & Dohme (MSD; NYSE: MRK) for its P2X3 receptor antagonist, gefapixant, which was being considered as a treatment for refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. The rejection was due…
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European Commission Expands Keytruda Indications for Advanced Cancer Treatments
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The European Commission (EC) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) additional indications for its leading anti-PD-1 therapy, Keytruda (pembrolizumab), approving its use as a first-line treatment in combination with chemotherapy for locally advanced unresectable or metastatic biliary tract carcinoma (BTC) and HER2-negative gastric or gastroesophageal junction (GEJ)…
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EMA’s CHMP Gives Green Light to Sanofi’s Fexinidazole for Acute Sleeping Sickness Treatment
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Last week, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on Sanofi’s (NASDAQ: SNY) Fexinidazole Winthrop (fexinidazole) as a 10-day treatment for acute sleeping sickness caused by Trypanosoma brucei (T.b.) rhodesiense in both adults and children. The EMA is…
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BGI Genomics Receives NMPA Approval for Innovative Colorectal Cancer Detection Kit
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BGI Genomics Co., Ltd. (SHE: 300676), a leading genomics firm based in China, has announced the approval of its medical device license from the National Medical Products Administration (NMPA) for a novel gene methylation detection kit. The kit employs fluorescence PCR technology to assess the combined methylation status of the…
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Keytruda Gains 12th Indication Approval in China for HER2-Negative Gastric Cancer
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US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its immunotherapy drug Keytruda (pembrolizumab) has received approval from the National Medical Products Administration (NMPA) in China for a new indication. The drug is now approved as a first-line treatment for locally advanced unresectable or metastatic HER2-negative…
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Roche Receives NMPA Approval for Ophthalmology BsAb Vabysmo (Farcimab) for Diabetic Macular Edema
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has obtained marketing approval from China’s National Medical Products Administration (NMPA) for its ophthalmology bispecific antibody (BsAb) Vabysmo (faricimab), which is indicated for the treatment of diabetic macular edema (DME). Vabysmo targets both vascular endothelial growth factor A (VEGF-A) and…
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FDA Approves Pfizer-Astellas-MSD Combo Therapy for Advanced Urothelial Cancer
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Pfizer (NYSE: PFE), Astellas (TYO: 4503), and Merck, Sharp & Dohme (MSD; NYSE: MRK) have secured U.S. Food and Drug Administration (FDA) approval for their combination therapy consisting of Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) for the treatment of locally advanced or metastatic urothelial cancer (la/mUC). The FDA’s decision is…
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Sanofi’s Rezurock Secures Marketing Approval in China for Chronic Graft-vs-Host Disease
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that its drug Rezurock (belumosudil), the world’s first and only ROCK2 inhibitor for the treatment of chronic graft-versus-host disease (cGVHD), has received marketing approval in China. Clinical data indicates that Rezurock achieves a 75% overall response rate (ORR), a 75% 6-month failure-free…
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MSD’s Welireg Gains FDA Approval for Advanced Renal Cell Carcinoma
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The US Food and Drug Administration (FDA) has granted an indication extension approval for Merck, Sharp & Dohme’s (MSD; NYSE: MRK) oral drug Welireg (belzutifan), expanding its use as a therapy for advanced renal cell carcinoma (RCC) in adults who have previously received a PD-1/L1 inhibitor and a VEGF tyrosine…
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MicroPort MedBot’s R-ONE Vascular Intervention Robot Approved by China’s NMPA
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) has announced that it has received market approval from China’s National Medical Products Administration (NMPA) for its R-ONE vascular intervention surgical robot. The robot was introduced by Cathbot, a joint venture between MicroPort and French firm Robocath S.A.S in China. R-ONE, a…
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Sino Medical Sciences Secures Market Approvals in Hong Kong, China, and Malaysia for Medical Devices
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China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced receiving market approvals for two of its medical devices in Hong Kong, China, and Malaysia. The NC Rockstar non compliant coronary artery balloon dilation catheter has been approved in Hong Kong and China, while the HT Supreme drug eluting stent…
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Luye Pharma’s Lurbinectedin Receives Market Approval in Hong Kong for SCLC Treatment
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China-based Luye Pharma Group (HKG: 2186) has announced that Hong Kong’s pharmacy and poisons board has approved a market approval filing for the company’s lurbinectedin (LY01017), a drug indicated for metastatic small-cell lung cancer (SCLC) in patients with tumor progression during or after platinum-based chemotherapy. The approval, facilitated by the…
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Cryofocus Medtech Receives NMPA Approval for Complete Cardiac Cryoablation System
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Cryofocus Medtech (Shanghai) Co., Ltd. (HKG: 6922), a Shanghai-based specialist in cryoablation treatment, has announced that it has received marketing approvals from China’s National Medical Products Administration (NMPA) for all components of its cardiac cryoablation system. The approvals include the cryoablation equipment, balloon type cryoablation catheter (previously known as the…
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Zylox-Tonbridge Medical Technology’s ZENFLOW T18 Receives NMPA Marketing Approval
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Zylox-Tonbridge Medical Technology (HKG: 2190), a 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 in-house developed ZENFLOW T18 peripheral balloon dilation catheter. The ZENFLOW T18 is a conical balloon designed…
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Pfizer and CStone Secure NMPA Approval for Sugemalimab, First PD-L1 Inhibitor for ESCC
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Pfizer (NYSE: PFE) and CStone Pharmaceuticals (HKG: 2616) have secured market approval from the National Medical Products Administration (NMPA) for sugemalimab, a treatment for first-line irresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) in combination with fluorouracil and platinum. This approval marks sugemalimab as the first programmed…
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AK Medical Secures NMPA Approval for Advanced 3D-Printed Hip Prosthesis Component
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China-based AK Medical Holdings Ltd (HKG: 1789) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its Acetabular Component of Hip Prosthesis, classified as a Class III medical device. This innovative product is a 3D-printed titanium alloy orthopedic implant. AK Medical first gained…
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Bio-Thera Secures FDA Approval for Avzivi, a Biosimilar to Roche’s Avastin
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that it has received market approval from the U.S. Food and Drug Administration (FDA) for Avzivi (bevacizumab), a biosimilar version of Roche’s (SWX: ROG) Avastin. The approved indications for Avzivi include non-small cell lung cancer (NSCLC), metastatic colorectal cancer (mCRC), glioblastoma (GBM), renal…
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Antengene Secures NDA Approval for Xpovio in Macau for Advanced Multiple Myeloma
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Antengene Corp., Ltd. (HKG: 6996), a biopharmaceutical company based in China, has announced that it has received New Drug Application (NDA) approval from the regulatory authority in Macau for its product Xpovio (selinexor). This approval is specifically for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R…
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Novartis’ Fabhalta Wins FDA Nod as First-in-Class Treatment for Paroxysmal Nocturnal Hemoglobinuria
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has secured regulatory approval from the US Food and Drug Administration (FDA) for its first-in-class orphan drug Fabhalta (iptacopan) as an oral monotherapy for adults with paroxysmal nocturnal hemoglobinuria (PNH). The approval was granted based on Phase III clinical data that demonstrated a significant…
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Sinocare Inc’s Blood Glucose Monitoring System Earns US FDA Approval
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Sinocare Inc (SHE: 300298), a Chinese medical device company, has announced that it has received market approval from the US Food and Drug Administration (FDA) for its TRUNESS/ TRUNESS AIR blood glucose monitoring system product. The TRUNESS blood glucose monitoring system includes the TRUNESS blood glucose meter and corresponding test…
