Capsida Biotherapeutics stops enrollment in its SYNRGY clinical trial that is evaluating gene therapy CAP-002 for treating STXBP1 developmental and ep...
FDA commissioner Marty Makary reinstates CBER director Vinay Prasads previous additional duties as the agencys chief medical and scientific officer.
FDA approves an expanded indication to include pediatric patients aged one and older for AstraZenecas Koselugo to treat some cases of neurofibromatosi...
FDA publishes a draft guidance to assist in developing non-opioid analgesics to treat chronic pain.
FDA clears a new indication for neurocare groups Apollo TMS therapy device to treat adolescents with major depressive disorder.
FDA approves a Johnson & Johnson NDA for Inlexzo (gemcitabine intravesical system) for adults with non-muscle invasive bladder cancer who do not respo...
FDA grants Greenwich LifeSciences fast track status for GLSI-100 for preventing breast cancer recurrences.
In a new crackdown on drug advertising, FDA orders pharmaceutical companies to remove any noncompliant ads and bring all promotional communications in...
