The U.S. FDA has greenlit the first steps of Uniqure NV’s accelerated approval pathway for gene therapy AMT-130 to treat Huntington’s disease. The agency said data from the ongoing phase I/II studies ...
Positrigo AG is raising $10 million for production and commercialization of its Neurolf brain positron emission tomography system in the U.S. The system hepls to diagnose Alzheimer’s disease. With ...
Dewpoint Therapeutics Inc. and Mitsubishi Tanabe Pharma Corp. have entered a research collaboration worth up to $480 million ...
The FDA’s final guidance for predetermined change control plans (PCCPs) for AI products contains a number of editorial ...
Takeda Pharmaceutical Co. Ltd. is licensing Keros Therapeutics Inc.’s activin inhibitor elritercept in a global development and commercialization deal worth up to $1.3 billion that excludes mainland ...
Agios Pharmaceuticals Inc. is learning the hard way the downside of having a pipeline in a product. When a side effect crops ...
Following its $60 million investment in Axiom Space Inc. last year, Boryung Co. Ltd. made a $10 million private placement in ...
Medicare coverage of FDA-designated breakthrough devices is still a policy hot topic. Although the House of Representatives generated some momentum on related legislation, the Senate is now examining ...
Less than three months after going public via a $227.7 million IPO, shares of Bioage Labs Inc. (NASDAQ:BIOA) took a hit Dec. 9, losing 77% of their value, as safety concerns prompted the company to ...
Citryll BV has closed an €85 million (US$89.8 million) series B, enabling it to take CIT-013, an antibody designed to block pathological neutrophil extracellular traps that drive a wide range of ...
Nua Surgical Ltd. secured €6.5 million ($6.9 million) in series A financing to support regulatory clearance in the U.S. and early commercialization of its Stericision C-section retractor. The device ...
Enanta Pharmaceuticals Inc. hit the mark that Wall Street hoped for, and details rolled out in top-line results from the first-in-pediatrics phase II study evaluating once-daily, oral zelicapavir in ...