Federal Register notice: FDA announces the issuance of a priority review voucher to X4 Pharmaceuticals in response to gaining approval of a rare pedia...
FDA qualifies the Assessment of IntraOcular Lens Implant Symptoms patient-reported instrument as a medical device development tool.
Lilly says its once-weekly insulin efsitora alfa met endpoints in two trials with insulin-nave adults with Type 2 diabetes.
FDA updates a Draeger Class 1 recall (device correction) of the Perseus A500 anesthesia workstation after receiving reports that the internal backup b...
Biogen and Ionis Pharmaceuticals discontinue the development of BIIB105 (ION541), an investigational antisense oligonucleotide for amyotrophic lateral...
CDER review chemist Andrei Ponta discusses the recent guidance on nanomaterials in drugs and biologics on a Center small business assistance podcast.
The Sedgwick Recall Index for the first quarter of 2024 shows a drop in drug recalls and an increase in medical device recalls.
In an ongoing review of problems with plastic syringes made by some manufacturers in China, FDA says it has imposed an Import Alert on two companies t...
