“It is the FDA’s role to ensure that drugs are safe and effective,” said Patrizia Cavazzoni, MD, director of the agency’s Center for Drug Evaluation and Research (CDER). “Based on our ...

The US Food and Drug Administration on Monday approved Hikma Pharmaceuticals’ generic version of Novo Nordisk’s diabetes drug, Victoza, clearing the way for the launch of another copy of the ...

This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the ...

For some perspective, as of June 2024, the FDA received 1,516 requests for this designation, and only 587 have been granted. This is in line with previous years, during which around 30-40% of ...

For every illegal drug, there is a combination of emojis that dealers and consumers use to evade detection on social media and messaging platforms. Snowflakes, snowfall, and snowmen symbolize cocaine.

The US Food and Drug Administration has placed its most serious warning – a so-called black-box warning – on a drug used to relieve menopausal hot flashes. The FDA says women who are taking ...

LONDON, Dec 17 (Reuters) - A new long-acting preventive HIV drug could reach the world’s poorest countries by the end of 2025 or early 2026, a global health official told Reuters on Tuesday.

"A version of this article was published first on Hyman, Phelps & McNamara’s FDA Law Blog. It is republished here with permission." In November, President-Elect Trump announced his pick of Robert ...

美国 FDA 于 12 月 12 日宣布成立药品审评和研究中心（CDER）真实世界证据创新中心（CDER Center for Real-World Evidence Innovation，CCRI），以协调和促进真实 ...

On December 12, 2024, FDA’s Center for Drug Evaluation and Research (CDER) announced a new CDER Center for Real-World Evidence Innovation (CCRI). The CCRI is intended to serve as the focal point ...

People with missing teeth may be able to grow new ones, say Japanese dentists testing a pioneering drug they hope will offer an alternative to dentures and implants. Unlike reptiles and fish, which ...