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

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 ...

New interim data from a Phase III trial puts the company on track to file for FDA approval next year in an indication that ...

Aldeyra Therapeutics reports positive results from phase 2 clinical trial in alcohol-connected hepatitis: Lexington, Massachusetts Thursday, October 30, 2025, 17:30 Hrs [IST] Alde ...

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 ...

Ascletis expects to submit an Investigational New Drug Application (IND) for ASC36 for the treatment of obesity to the US Food and Drug Administration (FDA) in the second quarter of 2026. ASC36, an ...

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 ...

IMM-529 IND: currently under review, FDA request for Information - minor updates to clinical protocol completed and submitted Travelan® P2TD (n=851) Uniformed Services University study topline data de ...

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 ...