FDA/CDC
FDA/CDC
FDA panel votes to approve Pfizer’s vaccine for children
If the FDA follows the recommendation, as it typically does, ...the shots could be available within days.
FDA/CDC
FDA clears 5-minute test for early dementia
FDA/CDC
FDA authorizes boosters for Moderna, J&J, allows mix-and-match
The move gives the vaccine experts on the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices latitude to...
FDA/CDC
White House announces vaccination plans for younger children
The shots could be available in early November.
FDA/CDC
FDA proposes new rule for over-the-counter hearing aids
The action comes nearly 5 years after Congress passed a law to allow over-the-counter sales for people with mild to moderate hearing loss.
Latest News
FDA approves combo pill for severe, acute pain
Seglentis contains 56 mg of celecoxib and 44 mg of tramadol.
FDA/CDC
FDA OKs new high-dose naloxone product for opioid overdose
“The higher intramuscular doses of naloxone in ZIMHI should result in more rapid and higher levels of naloxone in the systemic circulation.”
FDA/CDC
FDA panel backs second dose for Johnson & Johnson vaccine recipients
It will be up to a Centers for Disease Control and Prevention (CDC) panel to make more specific recommendations for who might need another shot....
FDA/CDC
FDA advisors vote to recommend Moderna boosters
The panel voted to authorize a 50 milligram dose — half the dose used in the primary series of shots — to boost immunity against COVID-19 at least...
Conference Coverage
‘Impressive’ results for novel antidepressant, so why the FDA delay?
Results showed the drug had a clinical response rate of 80% and a remission rate of almost 70%.