Academic medical center researchers worldwide call on FDA to pause its approval of Biogens Aduhelm to treat Alzheimers disease while it investigates t...
Attorney Steven Boranian praises a California Court of Appeal decision invoking federal preemption in a failure-to-warn case involving the heart drug ...
FDA denies two Informed Consent Action Network petitions seeking agency action to modify emergency use authorizations for Covid-19 vaccines.
Four Morrison Foerster attorneys list several FDA-focused takeaways from a recent panel presentation on compliance and cybersecurity challenges in cli...
CBER issues two new Standard Operating Policies and Procedures covering BLAs, NDAs and their supplements and product licenses.
The NEST Collaborating Community issues a draft playbook on using medical device unique device identifiers at the point of care.
GSK says a Phase 2a study showed that GSK3036656, an investigational antitubercular agent, was well tolerated and showed early bactericidal activity w...
FDA approves an expanded use for GE Healthcares DaTscan (ioflupane I 123 injection) for use in patients with suspected dementia with Lewy Bodies.
