FDA outlines a new pilot program on using novel excipients with the intent to increase their use in drug development, especially if they have potentia...
Janssen Pharmaceutical files a supplemental BLA for Stelara (ustekinumab) for treating pediatric patients aged five years and older with juvenile psor...
FDA grants Genentech a breakthrough therapy designation for gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration in A...
FDA issues a warning to health care professionals to not use needle-free devices such as hyaluron pens for injecting hyaluronic acid or other lip and...
FDA reclassifies surgical staplers for internal use from Class 1 to Class 2 and delays enforcement of the change for 180 days.
NeuroMetrix submits a de novo request for its Quell wearable neuromodulation device for treating symptoms of fibromyalgia in adults.
Federal Register notice: FDA announces a 10/14-15 Vaccines and Related Biological Products Advisory Committee meeting.
Federal Register notice: FDA releases a revised draft guidance entitled Hospital and Health System Compounding Under Section 503A of the Federal Food,...