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 ...

In a regulatory filing made on Saturday (24 May 2025), the company informed that the US FDA had conducted a GMP inspection at ...

Susvimo is also approved to treat diabetic macular edema and age-related macular degeneration, and the medication, ...

Susvimo is the first and only FDA-approved, continuous delivery treatment shown to maintain vision in people with DR with ...

Federal health agencies were alerted in February 2021 to “large reports of myocarditis” in young people who received the Pfizer vaccine, but waited until late June to adjust the ...

Bayer’s Jivi is a factor VIII replacement therapy that has been engineered with a compound that allows for less frequent dosing. It is now indicated for patients 7 years of age and older.

The inspection by the U.S. Food and Drug Administration (FDA) focused on the company's active pharmaceutical ingredients (API ...

FDA inspections are essential to ensuring the safety and quality of products in the food, pharmaceutical, and medical device industries. One of the experienced professionals in this field is John ...