FDA/CDC
FDA/CDC
FDA grants new indication to lumateperone (Caplyta) for bipolar depression
This makes lumateperone the only FDA-approved drug for adults with depressive episodes associated with bipolar I and II disorder.
Latest News
COVID cases spike as questions remain about Omicron’s threat
The Omicron variant has been detected in at least 39 states and 75 countries, according to CDC director Rochelle Walensky, MD.
FDA/CDC
Califf plans work on opioids, accelerated approvals on return to FDA
In emphasizing the need for continued efforts to address risks of painkillers, Biden’s FDA nominee cites his relatives’ experience in getting 30-...
FDA/CDC
Record-breaking autism rates reported with new CDC criteria
Taken together, the data suggest efforts to raise awareness about autism are working, though researchers were quick to say much work remains.
FDA/CDC
FDA panel backs first pill for COVID-19 by a small margin
If authorized by the agency, molnupiravir would be first antiviral agent available as a pill to treat COVID-19.
FDA/CDC
FDA puts clozapine REMS requirements on temporary hold
“We encourage pharmacists and prescribers to continue working with the clozapine REMS to complete certification and patient enrollment,” the FDA...
FDA/CDC
CDC unveils mental health protection plan for health care workers
“It’s long past time for us to care for the people who care for all of us and address burnout in our health care workers,” said U.S. Surgeon...
News from the FDA/CDC
CDC: Thirty percent of hospital workers in U.S. still unvaccinated
Health care personnel “are not fully immune from vaccine misinformation.”
FDA/CDC
FDA authorizes COVID boosters for all U.S. adults
The CDC’s Advisory Committee on Immunization Practices will meet on Nov. 19 to review the science supporting a more widespread need for booster...
FDA/CDC
U.S. overdose deaths hit an all-time high
Fentanyl and methamphetamine are contributing to rising numbers of fatalities, federal officials say.
FDA/CDC
Biden seeks to return Califf as FDA chief
President Joe Biden said on Nov. 12 that he’ll nominate Robert Califf, MD, to be commissioner of the U.S. Food and Drug Administration once again...