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In November 2023, the FDA revised the EUA for nirmatrelvir/ritonavir to authorize EUA- or NDA-labeled nirmatrelvir/ritonavir for the treatment of mild-to-moderate COVID‑19 in people aged twelve years of age and older weighing at least 40 kilograms (88 lb), who are at high risk for progression to severe COVID‑19, including hospitalization. [18]
Research in March 2020 found no evidence to justify stopping these medications in people who take them for conditions such as high blood pressure. [ 5 ] [ 93 ] [ 94 ] [ 95 ] One study from April 2020 found that people with COVID-19 and hypertension had lower all-cause mortality when on these medications. [ 96 ]
The FDA's budget for approving, labeling, and monitoring drugs is roughly $290 million per year [citation needed]. The safety team monitors the effects of more than 3,000 prescription drugs on 200 million people with a budget of about $15 million a year [citation needed]. Patrizia Cavazzoni is the current director of CDER. [1]
Ensitrelvir has been investigated for use as potential post-exposure prophylaxis (PEP) for SARS-CoV-2 infection. [20] [21] The SCORPIO-PEP trial, a global Phase 3 study, assessed the safety and efficacy of ensitrelvir in preventing symptomatic COVID-19 among household contacts of individuals with confirmed SARS-CoV-2 infection.
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That’s a common reaction: A recent study found that 30-90% of people who got the COVID vaccine experienced some type of side effect, which can appear within 1–3 days after you get immunized.
On July 15, the CDC alarmed health care groups by temporarily removing COVID-19 dashboards from its website. It restored the data a day later. [132] [133] [134] In August 2020, the CDC recommended that people showing no COVID-19 symptoms do not need testing. The new guidelines alarmed many public health experts. [135]
The U.S. Food and Drug Administration on Tuesday approved Merck's treatment for adults with high blood pressure due to constriction of lung arteries, adding another potential blockbuster drug to ...