FDA/CDC
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.
News from the FDA/CDC
Delta becomes dominant coronavirus variant in U.S.
FDA/CDC
Pfizer halts distribution of stop-smoking pill Chantix
The distribution pause was ordered out of abundance of caution while further testing is conducted.
FDA/CDC
FDA fast-tracks lecanemab for Alzheimer’s disease
The drug is a humanized monoclonal antibody that selectively binds to large, soluble aggregated Abeta protofibrils.
FDA/CDC
FDA leader explains rationale leading to controversial Alzheimer’s drug approval
In view of the “fierce public debate” that erupted immediately following the drug’s approval, the FDA felt compelled to explain how it reached its...
Opinion
Few clinical guidelines exist for treating post-COVID symptoms
‘We can prevent many infections from this virus, but we are still left to manage many post-COVID symptoms,’ says Dr. Linda Girgis.
FDA/CDC
FDA to add myocarditis warning to mRNA COVID-19 vaccines
But a CDC advisory panel, where the FDA made the announcement, still strongly backs the vaccines’ benefits, which outweigh the rare risk for heart...