With reports that FDA’s AI Elsa is “confidently hallucinating” studies that don’t exist, the use of AI to streamline drug review and speed up approval is not here yet.

The FDA has decided not to approve glofitamab plus gemcitabine and oxaliplatin to treat certain patients with relapsed/refractory DLBCL.

WuXi Biologics secures US FDA Pre-License Inspection approval for five facilities, first for commercial PFS line: Wuxi, China Wednesday, July 23, 2025, 13:00 Hrs [IST] WuXi Biolog ...

In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...

A Mayo Clinic study confirmed the accuracy of a new FDA-approved blood test for early detection of Alzheimer's disease.

Roche is focusing on early diagnosis of Alzheimer's disease and will soon release its first blood-based biomarker for the ...

A meeting Wednesday at the Food and Drug Administration about fluoride supplements became, at one point, a contentious back-and-forth over whether the ingestible tablets harm children’s microbiomes or ...

Engagement with FDA on GH001 IND complete response ongoingThe fully completed Open-Label Extension analysis confirms a 73% remission rate at 6 months with infrequent treatment visits and no ...

Engagement with FDA on GH001 IND complete response ongoingThe fully completed Open-Label Extension analysis confirms a 73% remission rate at 6 months with infrequent treatment visits and no psychother ...

The Trump administration‘s “Make America Healthy Again” goals depend on negotiations with food and healthcare industry leaders rather than regulation, the heads of the Food and Drug Administration and ...

Viatris offers value with high free cash flow and dividends but faces growth challenges from legacy drug price erosion and ...

U.S. District Judge Paula Xinis issued a memorandum prohibiting the Department of Homeland Security from “taking Abrego ...