Qiagen NV added to its growing roster of panels cleared by the U.S. FDA in 2024 with the agency’s nod for its Qiastat-Dx Meningitis/Encephalitis assay. The clearance validates Qiagen’s strategy of developing rapid tests specifically for the U.S. market and builds on the respiratory, gastrointestinal and central nervous system tests already available.
Hifibio Therapeutics Inc. has gained IND clearance from the FDA for HFB-200604, a potentially best-in-class BTLA agonist monoclonal antibody for inflammatory and immunology diseases.
Damona Pharmaceuticals Inc. has obtained IND clearance from the FDA for DPX-101 for the treatment of cognitive deficits in brain disorders, including major depressive disorder.
Disc Medicine Inc. found itself after an end-of-phase II meeting with the U.S. FDA in what Wainwright analyst Douglas Tsao called a “best-case scenario” regarding the path forward for bitopertin in erythropoietic protoporphyria (EPP).
The U.S. FDA reported a class I recall of tracheostomy tube kits by Minneapolis-based Smiths Medical Inc., because of the risk of separation of the tube’s pilot balloon and inflation line.
Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture 2024 conference in New York.
The second time around wasn’t lovelier for Lexicon Pharmaceuticals Inc. as it once again made its case before the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee for Zynquista (sotagliflozin) as an adjunct to insulin to improve glycemic control in people with type 1 diabetes and mild to moderate chronic kidney disease.
Abionic SA received U.S. FDA 510(k) clearance for its in vitro diagnostic Capsule pancreatic stone protein (PSP) sepsis test. Produced by the pancreas and immune cells, PSP provides an early biomarker for sepsis that could push back detection of deadly condition by 24 to 48 hours.
The FDA has granted orphan drug designation to Capsida Biotherapeutics Inc.’s CAP-002, an investigational gene therapy for the treatment of developmental and epileptic encephalopathy due to syntaxin-binding protein 1 (STXBP1) mutations.
Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture 2024 conference in New York. The agency is trying to set up cell and gene companies for success and that’s a very different agency than what it was years ago, said Paul Bresge, CEO of Ray Therapeutics Inc.
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