The U.S. Food and Drug Administration, together with Roche Laboratories, Inc., the maker of Tamiflu (oseltamivir), have informed health care professionals of neuropsychiatric events associated with use of the antiviral drug in patients with influenza. The Tamiflu package insert has been updated to reflect these safety concerns.
FDA approves Pfizer’s maternal vaccine to prevent RSV in infants
August 21st 2023Approved for use at 32 weeks through 36 weeks gestation, Pfizer’s maternal respiratory syncytial vaccine (Abrysvo), is delivered through a single dose injection to the muscle, and is the first vaccine for use in pregnant individuals to prevent lower respiratory tract disease (LRTD) and severe LRTD because of RSV in infants (birth to 6 months).
Combination test for COVID-19, influenza A/B, RSV receives FDA 510(k) clearance
August 3rd 2023Previously available under an Emergency Use Authorization, the combination test can detect and distinguish COVID-19, influenza A/B, and respiratory syncytial virus (RSV). The clearance comes ahead of respiratory season, which, according to BD, could result in another “tripledemic” threat.
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