FDA/CDC
FDA/CDC
FDA stands firm on deadline for clozapine REMS recertification
Prescribers and pharmacies who fail to be certified by Nov. 15 will no longer be able to prescribe/dispense the drug.
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
Pandemic drives uptick in need for mental health services
Women were more likely than men to have received any mental health treatment (25.6% vs 14.6%), according to an analysis of 2020 data.
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
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%.
News from the FDA/CDC
Johnson & Johnson requests FDA approval for vaccine booster doses
The FDA’s independent vaccine advisory committee meets next week to review data on booster shots from both Johnson & Johnson and Moderna.
FDA/CDC
FDA okays new oral CGRP antagonist for migraine prevention
With this approval, neurologists will be able to choose from four monoclonal antibodies and two gepants for the preventive treatment of migraine...