Infectious disease
The FDA intends to place a black box label—its most serious warning—on COVID-19 vaccines, according to reporting by CNN. It is unclear if the warning would apply to Moderna’s, Pfizer/BioNTech’s and Novavax’s shots, or to all age groups.
Blujepa is also approved for uncomplicated urinary tract infection in females 12 years and older.
The 2024–2025 formulations of COVID-19 vaccines had an effectiveness rate of 76% at preventing emergency or urgent care visits in children aged 9 months through four years, according to a new report.
A mid-stage study for ABI-5366 will begin mid next year, while Assembly continues to assess the Phase II potential of ABI-1179.
Last week, Center for Biologics Evaluation and Research Director Vinay Prasad claimed in an internal memo—without providing evidence—that COVID-19 vaccines were responsible for the deaths of 10 children between 2021 and 2024.
With no evidence to support the claim that 10 children died due to COVID-19 vaccines, experts unpack the impact of CBER chief Vinay Prasad’s leaked vaccine memo.
This week’s meeting of the Advisory Committee on Immunization Practices will be led by Kirk Milhoan, a physician and pastor who recently claimed that COVID-19 vaccines contained a contamination that causes cancer.
The alleged deaths were detected by the FDA’s Vaccine Adverse Event Reporting System, reports from which “generally cannot be used to determine” causation or even contribution, according to the agency.
The FDA’s docket in December includes decisions for two big biologic franchises: BMS’s Breyanzi and Amgen’s Uplizna.
At $9.2 billion, the Cidara acquisition lands among the top 5 largest deals of the year.
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