FDA grants PureTech Health a fast-track designation for LYT-200 in combination with anti-PD1 therapy for treating recurrent/metastatic head and neck s...
FDA grants 16 Bit Inc. a de novo marketing authorization for Rho, an AI-enabled software device aimed at improving osteoporosis screening.
As FDA continues to evaluate the risk of suicidal thoughts or actions in patients taking glucagon-like peptide-1 receptor agonists, the European Medic...
FDA approves new safety labeling for Veloxis Pharmaceuticals Envarsus XR (tacrolimus), indicated for use with other medicines to help prevent organ re...
Oncolytics Biotech asks FDA for a 2nd quarter Type C meeting to agree on the design and objectives for a registration-enabling trial of its pelareorep...
FDA releases the form FDA-483 with six observations from an inspection at the Cipla API and drug manufacturing facility in Ragaid, Maharashtra, India.
FDA grants breakthrough device designation to a Roche blood test intended to aid in a diagnosis of Alzheimers disease based on amyloid pathology.
FDA approves an AstraZeneca supplemental BLA for Fasenra (benralizumab) as an add-on maintenance treatment for patients with severe asthma aged 6 to 1...
