Genentech's ranibizumab injection (Susvimo) has received FDA approval for the treatment of diabetic retinopathy. The ...

For any FDA-approved facility, it is mandatory to conform to the US regulator's cGMP or current Good Manufacturing Practice ...

At least twice as many patients on the approved spesolimab dose maintain improvement in skin symptoms and quality of life ...

Runaway cell death and inflammation triggered by severe trauma may be interrupted by a drug used to prevent alcohol abuse – ...

FDA places clinical hold of RP-A501 for the treatment of patients with Danon disease due to a patient death. Click here to ...

Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can ...

In calling for more clinical testing of vaccines in younger people and those who face a low risk of severe disease from Covid ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its ...

Hyderabad: Dr Reddy's Labs has announced that the United States Food & Drug Administration (USFDA) has issued two ...

Dr Reddys Laboratories said that the United States Food & Drug Administration (US FDA), post a GMP inspection, has issued a Form 483 with 2 observations to the company's Telangana-based manufacturing ...