The U.S. Food and Drug Administration has appointed George Francis Tidmarsh, M.D., Ph.D., as director of the Center for Drug Evaluation and Research (CDER).

Dr. James H. Bekker made it clear while standing at a podium in front of the U.S. Food and Drug Administration (FDA) in ...

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Brad Stewart, BDO’s national life ...

We need a dedicated framework that clarifies the rules, requirements and incentives for those building personalized ...

The Trump administration is inching closer to banning fluoride tablets and drops often prescribed to kids who don’t have ...

Syngene International reported a 61% year-on-year increase in its Q1 profit after tax, reaching ₹87 crore. This growth was driven by revenue expansion and cost optimisation.

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.

The US health regulator has pulled up Glenmark Pharmaceuticals for manufacturing lapses, including failure to establish laboratory controls, at its Pithampur-based plant.      In a warning letter, the ...

Explore the FDA’s 2025 Human Foods Program Guidance Agenda and what it means for US food and beverage businesses. Key ...

On Monday morning, the FDA hosted a 10-person expert panel on the use during pregnancy of SSRIs, which include medications like fluoxetine (Prozac), sertraline (Zoloft) and citalopram (Celexa), among ...

Pharma major Dr. Reddy's Laboratories reported a marginal 2% year-on-year (YoY) growth in its consolidated net profit at Rs 1 ...

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is getting better, and use is not mandatory.