After a patient safety signal and then death, the FDA in October 2025 placed holds on two of the company’s CRISPR programs ...
Neuren shares FDA feedback on NNZ-2591 development plans in HIE and PTHS, with next steps and management insights. The post ...
For companies developing interchangeable biosimilars, the FDA guidance opens the door to more tailored, risk-based programs that may reduce reliance on costly comparative efficacy studies (CES). For ...
FDA’s Center for Biologics Evaluation and Research (“CBER”) recently issued a trio of new draft guidances to assist sponsors who are developing and conducting postapproval studies of cell and gene ...
SAN FRANCISCO, CA / ACCESS Newswire / September 30, 2025 / Jaguar Health (NASDAQ:JAGX) today announced that Jaguar family company Napo Pharmaceuticals (Napo) is providing the company’s novel ...
The U.S. Food and Drug Administration (FDA) recently launched two initiatives to help onshore U.S. pharmaceutical manufacturing: the FDA PreCheck Program to streamline review of pharmaceutical ...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months ...
As part of its enforcement activities, the Food and Drug Administration (FDA) sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or ...
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