The device is implanted subcutaneously during an outpatient-compatible procedure.
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The SNOO facilitates a supine position during sleep for infants up to 6 months of age who are not yet able to roll over consistently.
If approved, Opill would be the first daily oral contraceptive pill available without a prescription.
An FDA panel has voted in favor of the safety and effectiveness of Paxlovid for COVID-19.
Previously, the treatment had been approved for patients 1 year of age and older.
Rezafungin is an investigational echinocandin antifungal that is administered once weekly.
The preliminary safety signal was identified by the CDC’s Vaccine Safety Datalink.
The guidelines were developed by a multidisciplinary workgroup.
The Emergency Use Authorization was based on safety and immunogenicity data provided to the Agency.