Fda-approvals
The US
Food and Drug Administration have approved the world's first vaccine Ixchiq for
chikungunya. “Infection with chikungunya virus can lead to
severe disease and prolonged health problems, particularly for older adults and
individuals with underlying medical conditions,”The most common symptoms of
chikungunya include fever and joint pain. O...
The U.S. Food and Drug
Administration approved the emergency use of the molnupiravir pill for the
treatment of mild-to-moderate coronavirus disease 2019 in nonhospitalized adult patients with positive
results of direct SARS-CoV-2 viral testing who are at high risk for progressing
to severe COVID-19, including hospitalization or death.Does molnu...
Nirmatrelvir and Ritonavir is the
first oral agent authorized by FDA (Emergency Use Authorization) for treatment
of mild-to-moderate coronavirus disease in adults and
pediatric patients.
In a randomized, double-blind,
placebo-controlled clinical trial, Nirmatrelvir and Ritonavir significantly
reduced the proportion of people with COVI...
The U.S. Food and Drug
Administration (USFDA) issued an emergency use authorization (EUA) for a new
monoclonal antibody for the treatment of COVID-19 that retains activity against
the omicron variant.
The EUA for Bebtelovimab is for the treatment of mild to moderate COVID-19 in
adults and pediatric patients (12 years of age and older we...
COVID-19 Update:In light of the most recent
information and data available, today, the FDA revised the authorizations for
two monoclonal antibody treatments – bamlanivimab
and etesevimab (administered together) and casirivimab and imdevimab – to limit their use to only when the
patient is likely to have been infected with or exposed to a varian...
The FDA announced it had amended
the emergency use authorizations for both the Moderna and Pfizer-BioNTech
vaccines allowing for a single booster dose for all individuals 18 years of age
and older after completion of primary vaccination with any of the approved COVID-19
vaccines.The CDC also recommends that
adults should get a booster at least...
The U.S. Food and Drug
Administration authorized Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir
tablets, co-packaged for oral use) for emergency use for the treatment of
mild-to-moderate coronavirus disease in adults and children 12 years and older weighing
at least 40 kilograms with positive results of direct SARS-CoV-2 testing, and who...
FDA authorized the emergency use of the Pfizer-BioNTech
COVID-19 Vaccine for the prevention of COVID19 to include
children 5 through 11 years of age.
Key points:
Effectiveness: Immune responses of
children 5 through 11 years of age were comparable to those of individuals
16 through 25 years of age. In addition, t...
The U.S. Food and Drug Administration
authorizes bamlanivimab and
etesevimab, administered together, to include emergency use as post-exposure
prophylaxis (prevention) for COVID-19 in adults and pediatric patients (12
years of age and older weighing at least 40 kg) who are at high risk for
progression to severe COVID-19, including hospitalizat...
Food and Drug Administration
advisory committee (US FDA) unanimously recommend the third shots to people age
65 and older and those at a high risk of suffering from severe illness if they
get the coronavirus.
Rejected a proposal to distribute
booster/third shots of Pfizer and BioNTech’s Covid-19 vaccine to the General Public. RemoveA...
The U.S. Food and Drug
Administration issued an emergency use authorization (EUA) for the drug
baricitinib, in combination with remdesivir, for the treatment of suspected or
laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two
years of age or older requiring supplemental oxygen, invasive mechanical...
The U.S. Food and Drug
Administration issued an emergency use authorization for the first antigen test
where results can be read directly from the testing card, a similar design to
some pregnancy tests. This simple design is fast and efficient for healthcare
providers and patients and does not need the use of an analyzer....
