The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to DPTX3186, an investigational therapy being ...

Glovadalen, a novel D1 receptor positive allosteric modulator, is linked to improve OFF time in patients with Parkinson’s ...

Shanghai Zhimeng Biopharma Inc. ( 'Zhimeng') announced that its self-developed new-generation potassium channel opener CB03-154 for the treatment of amyotrophic lateral sclerosis (ALS) has officially ...

Advancing preparations to begin manufacturing of fibroblast-based spheroids product candidate, CYWC628, for the Phase 1/2 clinical trial evaluating CYWC628 in diabetic foot ulcers (DFU) patients ...

Purple said that it has achieved a commercially viable yield for IM1240, positioning the program competitively for future ...

In Q3, Ibsrela saw highest demand since launch and recorded revenue of $78.2 million, marking a growth of 92%. ・Ardelyx’s net ...

Over the past generation, advances in treating common cancers—breast, lung, melanoma, and gastrointestinal (GI)—have improved ...

The NDA submission is supported by data from two pivotal Phase 3 clinical trials, which evaluated MK-6240’s performance in detecting tau pathology in early Alzheimer’s disease. These studies met their ...

October 2025 proved to be a significant month for the oncology landscape, marked by a wave of key regulatory decisions from the US FDA. This period saw important full and accelerated drug approvals ...

Three abstracts accepted for presentation, including one rapid oral abstract sessionPresentations to highlight ongoing clinical and translational research across PDS Biotechnology’s immunotherapy ...

The FDA can’t get out of the efficacy game.