Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...

The recall of more than 160,000 bottles of levothyroxine sodium, which went into effect June 20, was upgraded to a Class II recall on July 23. Class II recalls occur when use of the drug poses a ...

In recent years, Artificial Intelligence (AI) has made significant strides across various sectors, providing innovative solutions and enhancing efficiency. However, ...

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

Xuewu Liu, a Chinese inventor who has no medical training or credentials of any kind, is charging cancer patients $20,000 for ...

Sarepta has suffered another regulatory setback after the European Medicines Agency’s (EMA’s) Committee for Medicinal ...

You'll get access to an ad-free website with a faster photo browser, the chance to claim free tickets to a host of events ...

There was a lot of excitement when Tepezza became the first drug approved for the treatment of thyroid eye disease in January ...

An FDA panel meeting featured a heated dialogue over whether fluoride supplements could pose health risks to children. Here's ...