FDA says it has accepted an Echosens Letter of Intent to develop Liver Stiffness Measurement by Vibration-Controlled Transient Elastography as a surro...
FDA accepts for review a Grace Therapeutics NDA for GTx-104 (nimodipine for injection) for treating patients with aneurysmal subarachnoid hemorrhage.
Amylyx Pharmaceuticals discontinues development of its investigational therapy AMX0035 (sodium phenylbutyrate and taurursodiol) in progressive supranu...
FDA issues an alert after becoming aware that Abiomed sent a letter to customers recommending that certain automated Impella controllers be removed fr...
BioXcel Therapeutics plans an early 2026 supplemental NDA submission to expand the label of its agitation treatment Igalmi (BXCL501) for unsupervised ...
FDA warns Scottsdale, AZ-based Innate Healthcare Institute that it is illegally marketing adulterated and misbranded stem cell products.
FDA warns Uscom Kft about Quality System violations in its illegal manufacturing and marketing of adulterated spirometers at its facility in Budapest,...
FDA approves supplemental BLAs from Moderna and Pfizer/BioNTech for their mRNA Covid-19 vaccines that target the LP.8.1 variant of SARS-CoV-2; the age...
