Daré will host a conference call and live webcast today, May 13, 2025, at 4:30 p.m. Eastern Time to review financial results ...

The FDA will issue a decision on the BLA for RGX-121 by November, which if positive, could make it the first gene therapy for Hunter syndrome.

Vinay Prasad oversees vaccines, gene therapies and the blood supply. His views raise alarms for pharmaceutical companies and ...

Mineralys Therapeutics reports strong Q1 2025 results, announcing pivotal trial success for lorundrostat, a $201M equity raise, and progress toward ...

Recently, underscoring a commitment to national security, the White House and the Food and Drug Administration (FDA) issued separate ...

The Food and Drug Administration is rolling out an aggressive plan to make generative AI a linchpin in its decision-making, ...

Donald Trump has promised to create a pro-AI environment, but even tech companies are frustrated by federal cuts that hamper regulatory processes. Paul Webster reports.

Neurotechnology is advancing at an unprecedented pace, with brain-computer interfaces (BCIs) at the forefront of innovation. Over the past decade, BCIs have transitioned from experimental prototypes ...

FDA schedules End of Phase 2 meeting with Adial to discuss Phase 3 plans for AD04, its genetically targeted drug for Alcohol Use Disorder.

Dyne participated in a Type C meeting with the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) in May 2025 and discussed the path to regulatory approval, ...