FDA says it is delaying the PDUFA action date for Phathoms vonoprazan to treat erosive esophagitis while the company submits additional stability data...
As FDA prepares a review decision this week on an Eisai and Biogen BLA for Alzheimers drug lecanemab, an article in The Free Press reminds readers abo...
FDA publishes a guidance on the format and content for the REMS document portion of a REMS submission.
FDA says the Teleflex recall of some Arrow MAC venous catheter kits is Class 1.
FDA says the Arrow International recall of some intra-aortic balloon pumps for battery depletion issues is Class 1.
FDA posts the latest three months of potential signals of serious risks/new safety information for prescription drug products.
Reuters reports that several major drug companies are expected to raise list prices on some 350 drugs this month.
FDA clears a Vivos Therapeutics 510(k) for its daytime-nighttime appliance for treating obstructive sleep apnea and snoring in adults.
