FDA/CDC
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...
Latest News
CDC chief overrules panel, OKs boosters for health care workers
Panelists “did not buy the need in occupational or institutional settings.”
Latest News
FDA inaction on hair loss drug’s suicide, depression, erectile dysfunction risk sparks lawsuit
As an alternative, PFSF requested that the FDA require the drug’s manufacturers revise the safety information on the labeling and add boxed...
FDA/CDC
FDA approves first twice-yearly antipsychotic for schizophrenia
The approval is based on results from a 12-month, randomized, double-blind, phase 3 study that enrolled 702 adults with schizophrenia from 20...
FDA/CDC
FDA OKs stimulation device for anxiety in depression
The neurostimulation system has previously received FDA approval for refractory depression, obsessive-compulsive disorder, and smoking addiction...
News from the FDA/CDC
CDC officially endorses third dose of mRNA vaccines for immunocompromised
Just hours after the FDA updated its EUA for COVID vaccines, the CDC has recommended a third dose for those who are at higher risk for severe or...
FDA/CDC
FDA approves first drug for idiopathic hypersomnia
Xywav becomes the first medicine approved to manage this chronic sleep disorder.