Minneapolis-based Smiths Medical Inc., recalled two entries in the company’s CADD-Solis line of ambulatory infusion pumps due to problems with the preloaded software.
Actio Biosciences Inc.’s ABS-0871 has received both orphan drug designation and rare pediatric disease designation from the FDA. ABS-0871 is in preclinical development for the treatment of Charcot-Marie-Tooth disease subtype 2C (CMT2C).
Tr1x Inc. has announced that the FDA has cleared its IND application for its engineered Tr1 Treg cell therapy TRX-103 for treatment-refractory Crohn’s disease.
The U.S. FDA has granted accelerated approval to Novartis AG’s Fabhalta (iptacopan) for reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. The approval strengthens the company’s renal disease presence as it puts two other IgAN treatments through clinical trials.
China will deepen its health care reforms and will focus on enhancing its public health care capacity at the primary care level and at public hospitals, according to resolutions passed at the third plenary session of the 20th Central Committee of the Communist Party of China in July.
The U.S. CMS announced the release of the Transitional Coverage for Emerging Technologies policy, which is less than clear on the definition of a key term.
Twelve-month results from Fractyl Health Inc.’s real-world registry show sustained, significant weight loss following treatment with its Revita procedure, which uses ablation to resurface the mucosal lining of the duodenum.
Just ahead of the Aug. 13 PDUFA date, Citius Pharmaceuticals Inc. won the U.S. FDA’s go-ahead for Lymphir (denileukin diftitox-cxdl), a new immunotherapy for relapsed/refractory (r/r) cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The drug is Cranford, N.J.-based Citius’ first approved therapy and the only CTCL treatment that targets the interleukin-2 receptor found on malignant T cells and regulatory T cells. It’s also the first green light given by the FDA for r/r CTCL since 2018.
After receiving Orphan Drug Designation earlier this year, Satellos Bioscience Inc. announced that the FDA has granted Rare Pediatric Disease Designation to SAT-3247 for the potential treatment of Duchenne muscular dystrophy (DMD).
Chengdu Westgene Biopharma Co. Ltd. (Westgene) has received approval from both China's National Medical Products Administration (NMPA) and the FDA for its therapeutic cancer vaccine WGc-043 to enter first-in-human trials.
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