FDA warns Miramar, FL-based Kimera Labs about illegally manufacturing and distributing unapproved exosome products that have CGMP deviations.
FDA publishes a draft CDRH strategic plan for medical device international harmonization.
Three Ropes & Gray attorneys analyze three FDA draft guidances intended to modernize the 510(k) program, saying they are likely to be precursors to fu...
FDA says it is converting its medical device Accreditation Scheme for Conformity Assessment from a pilot to a permanent program.
A federal judge sentences Byron A. Marshall of Houston, TX to 300 months in federal prison for his role in leading a counterfeit drug trafficking sche...
Vanda Pharmaceuticals calls on FDA commissioner Robert Califf to throw out a second CDER proposed order on the companys sNDA for an expanded Hetlioz i...
Atara Biotherapeutics says it expects to file by 7/2024 a BLA for tabelecleucel, an allogeneic, Epstein-Barr virus-specific T-cell immunotherapy.
FDA grants InBrain Neuroelectronics a breakthrough device designation for its Intelligent Network Modulation System and its use as an adjunctive thera...
