FDA/CDC
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.
FDA/CDC
Heparin’s COVID-19 benefit greatest in moderately ill patients
A multiplatform trial reported that therapeutic heparin improved outcomes in moderately ill COVID-19 patients but not in critically ill patients...
FDA/CDC
FDA authorizes booster shot for immunocompromised Americans
Those eligible for a third dose include solid organ transplant recipients, those undergoing cancer treatments, and people with autoimmune diseases...
FDA/CDC
FDA to warn J&J that vaccine can increase Guillain-Barré risk: Media
The agency still calculates the benefit of vaccination with the J&J product continues to outweigh the risk.
FDA/CDC
FDA head calls for investigation into agency’s approval of aducanumab (Aduhelm)
An independent investigation will examine whether anything occurred that was “inconsistent with FDA policies and procedures.”
FDA/CDC
FDA updates label for controversial Alzheimer’s drug aducanumab (Aduhelm)
Revised labeling emphasizes that the drug should only be used in patients with the earliest stages of disease.