FDA/CDC
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...
News
Watchdog group demands removal of FDA leaders after aducanumab approval
“This decision is a disastrous blow to the agency’s credibility, public health, and the financial sustainability of the Medicare program,” critic...
Latest News
FDA approves controversial Alzheimer’s drug aducanumab (Aduhelm)
Approval was granted despite an FDA advisory panel recommendation not to approve the drug.
FDA/CDC
FDA okays new drug option for schizophrenia, bipolar I disorder
The FDA approved Lybalvi under the 505(b)(2) regulatory pathway based on data from 27 clinical studies.
FDA/CDC
FDA fast tracks testing of schizophrenia drug for impaired cognition
The breakthrough therapy designation and the initiation of phase 3 testing are based on results from a phase 2 clinical trial.
FDA/CDC
AHA reassures myocarditis rare after COVID vaccination, benefits overwhelm risks
As CDC investigates rare, mostly mild cases of myocarditis in adolescents and young adults given the Pfizer or Moderna vaccine, AHA emphasizes...