Expedited development and review programs established by the US Food and Drug Administration (FDA) have a growing role in bringing drugs and biologics to market, with novel orphan and nonorphan ...

The US Food and Drug Administration (FDA) on Tuesday provided updates on two programs negotiated under the Prescription Drug User Fee Act (PDUFA VII) meant to give sponsors an opportunity to engage ...

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 two programs are being conducted under separate Single-Patient Investigational New Drug (sIND) applications in the United States SAN FRANCISCO, CA / ACCESS Newswire / September 30, 2025 / Jaguar ...

Yesterday afternoon, Neuren Pharmaceuticals Ltd (ASX: NEU) shared feedback from recent US FDA meetings on its NNZ-2591 clinical programs. Neuren said it received constructive guidance for its ...

Domestic agencies would face $73 billion in cuts, including reduced funding for scientific research and health and ...