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 warns Westborough, MA-based Miach Orthopaedics about eight Quality System and three Medical Device Reporting violations in its production of the B...
The Biotechnology Innovation Organization says its congressional lobbying priorities for September are reauthorization of the FDA pediatric priority r...
FDA warns Chinas Jiangsu Kerbio Technology Group Co. about its violations of good laboratory practice regulations for nonclinical studies.
