FDA/CDC
FDA/CDC
Orally dissolving buprenorphine tied to severe tooth decay, FDA warns
Since buprenorphine was approved, the FDA has identified 305 cases of dental problems associated with orally dissolving buprenorphine.
FDA/CDC
COVID-19 linked to increased diabetes risk in youth
Two large databases indicate significantly increased diabetes risk among those with COVID-19 but not other acute respiratory illnesses.
FDA/CDC
CDC panel recommends Pfizer COVID-19 boosters for ages 12-15
CDC Director Rochelle Walensky, MD, must still approve the recommendation for it to take effect.
FDA/CDC
New CDC COVID-19 isolation guidelines still up for debate among experts
Sparking the most debate: Infected people are not told to test before leaving isolation.
FDA/CDC
FDA backs Pfizer booster for 12- to 15-year-olds
The agency also shortened the recommended time between a second dose and the booster to 5 months or more,
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...