Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genetika+, Medtronic, Sinaptica.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: .Amryt, Carsgen, Intelgenx, Jaguar, Kite, Kyverna, Lexeo, Nkgen, Noema, Prelude, Roche, Vitti, Zhiyu.
Rainmed Medical Ltd.'s coronary angiography-derived fractional flow reserve system (caFFR system) was approved by Australia’s TGA for precision diagnosis of coronary artery diseases.
Sino Medical Sciences Technology Inc. received marketing approval from China’s NMPA for its drug eluting stent system to improve vascular stenosis in patients with localized ischemic heart disease. The product is designed to improve the speed of wound healing and accelerate the recovery of vascular endothelium after stent implantation. It fits vessels with a diameter of 2.25 mm to 4.00 mm and a lesion length of less than or equal to 40 mm.
A vaccine for dengue fever, an advanced therapy for a complication after transplants, and a potential first-in-class drug for a form of psoriasis were among medicines recommended for approval by European regulators on Oct. 14.
The White House laid out several timelines Oct. 18 as part of a national biodefense strategy for countering biological threats and enhancing global pandemic preparedness.
South Korea’s drug regulator should consider revising orphan drug definitions or allow more new innovative drugs to be excluded from pharmacoeconomic assessments, which are required for new drugs to be reimbursed under Korea’s single-payer system, the European Chamber of Commerce in Korea said.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Heartflow, Proteomedix, SQI Diagnostics.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Biogen, Decibel, Eureka, GSK, Kira, Mereo, Minerva, Telix.
Curvebeam AI Ltd. won a U.S. FDA breakthrough device designation for Ossview, its investigational software that detects osteopenia or reduced bone mass in the already fragile bones of women 70 years of age and older. Osteopenia is difficult to diagnose using conventional bone mineral density (BMD) testing because small changes in density mask major changes in bone microstructure.
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