FDA says the Arizona federal court has approved a permanent injunction against Smart Womens Choice and its CEO to prevent them from illegally distribu...
Israels IceCure Medical says it is appealing an FDA denial of the companys de novo classification request for its ProSense cryoablation system for use...
Ascendis Pharma resubmits an NDA for TransCon PTH (palopegteriparatide) for treating adults with hypoparathyroidism.
FDA warns Chinas Ming Fai Industrial Co about QS violations in its production of ultrasound gel and probe cover products.
A lengthy FDA Warning Letter details issues at Indias Global Pharma Healthcare that led to contaminated ophthalmic drugs.
Bayer withdraws its NDA for Aliqopa (copanlisib) for adult patients with relapsed follicular lymphoma who have received at least two prior systemic th...
Federal Register notice: FDA renews the Nonprescription Drugs Advisory Committee for an additional two years.
Former Becton Dickinson medical director Hooman Noorchashm petitions FDA to warn patients about the unknown and inadequately studied effect of FDA-reg...
