FDA to investigate whether adult deaths linked to coronavirus vaccine

The agency also is reviewing safety of immunizations for RSV, according to manufacturers of the therapies who have been ...

FDA investigating whether coronavirus vaccines are linked to deaths

The Food and Drug Administration (FDA) is investigating whether the COVID-19 vaccines were associated with any deaths across ...
Becker's Hospital Review

The FDA’s new vaccine approval road map, explained

The FDA vaccine approval road map proposes longer trials and stricter evidence to improve vaccine safety and effectiveness oversight.

US FDA approves first drug under new fast-track review program

The U.S. Food and Drug Administration approved on Tuesday the first drug under its new fast-track program designed to shorten ...
Fierce Pharma

FDA awards 1st national priority nod to USAntibiotics' Augmentin XR

The inaugural approval under the program has gone to USAntibiotics and its domestically manufactured extended-release ...

Appointment of controversial FDA official rocking agency like "an atom bomb," scientists there say

The Trump administration's elevation of Dr. Tracy Beth Høeg to lead a high-profile office within the Food and Drug ...

FDA Slow Walking a Long-Awaited Abortion Pill Safety Study

The Food and Drug Administration has delayed a promised review of safety data for the abortion drug mifepristone at ...
CIDRAP

FDA approves US-manufactured antibiotic under new priority review program

The Food and Drug Administration (FDA) yesterday approved a US-manufactured version of the oral antibiotic Augmentin XR ...

US FDA launches fresh safety scrutiny of approved RSV therapies for infants

U.S. health regulators informed senior executives at Merck, Sanofi and AstraZeneca last week that their approved protective RSV treatments for infants would face fresh safety scrutiny following ...