FDA/CDC
News from the FDA/CDC
Clozapine interrupted: APA, others seek FDA forum on REMS
Clozapine can decrease the neutrophil count, which can lead to severe neutropenia, serious infection, and death.
FDA/CDC
CDC preparing to update mask guidance
“Omicron cases are declining, and we are all cautiously optimistic about the trajectory we’re on.”
FDA/CDC
Two emerging drugs exacerbating opioid crisis
On their own, para-fluorofentanyl and metonitazene can kill the user through respiratory depression, said Dr. Jordan Trecki.
FDA/CDC
FDA grants full approval to Moderna COVID-19 vaccine
The Moderna vaccine also now has a new trade name: Spikevax.
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.