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

Despite ambitions to streamline regulatory review, FDA’s Elsa platform has been prone to hallucinations, prompting internal scrutiny and questions about AI reliability and governance.

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, ...

Savara faces an FDA setback for Molbreevi, its aPAP treatment. Learn how the company plans to recover and file a new BLA by ...

USFDA issued a warning letter to Glenmark Pharmaceuticals for significant CGMP violations at its Pithampur plant, including failing to establish laboratory controls and adequate testing programs.

Replimune Group, Inc – a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies – ...

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

While dunking on former President Barack Obama, Tulsi Gabbard also took a swing at Donald Trump’s 2016 presidential campaign ...

PepsiCo and Dr Pepper have sold versions of their flagship sodas sweetened with cane sugar since 2009. Coca-Cola has sold ...

Gut health is finally becoming cool, which means more brands are touting the fiber available in their products.

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