FDA approves a resubmitted Acer Therapeutics NDA for its Olpruva to treat some patients with urea cycle disorders.
FDA warns The Woodlands, TX-based RoyalVibe Health about manufacturing, marketing, and distributing unapproved medical devices that are misbranded and...
FDA warns Sagent Pharmaceuticals about issues found in an inspection at its Plattsburg, NY-based sterile drug products manufacturing facility.
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.
