Key Takeaways “Pain reduction is a crucial component of living with chronic lower back pain. Today’s authorization offers a treatment option for pain reduction that does not include opioid pain medications when used alongside other treatment methods for chronic lower back pain,” Christopher M. Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in astatement. The treatment will be available for at-home use via prescription....

Key TakeawaysThe FDA recently approved a skin patch version of the drug donepezil to treat mild to severe Alzheimer’s-related dementia.This is the first Alzheimer’s treatment that is delivered through the skin.Unlike oral medications, the patch delivers a steady dose of the drug to maintain its effects on the brain.Adlarity is expected to hit the markets in early fall 2022. Key Takeaways The FDA recently approved a skin patch version of the drug donepezil to treat mild to severe Alzheimer’s-related dementia....

Key TakeawaysLilly’s monoclonal antibody treatment, called bebtelovimab, received FDA emergency use authorization for mild-to-moderate COVID.The drug appears to be effective against Omicron and other variants of concern.The FDA said the drug should be administered only when other treatment options aren’t accessible or clinically appropriate. Key Takeaways Lilly’s monoclonal antibody treatment, called bebtelovimab, received FDA emergency use authorization for mild-to-moderate COVID.The drug appears to be effective against Omicron and other variants of concern....

Key Takeaways On Thursday, the Food and Drug Administration (FDA) issued an emergency use authorization to the anti-inflammatory drug baricitinib to treat COVID-19 in combination with anti-viral drug remdesivir.Remdesivir earned full FDA approvalto treat hospitalized patients with COVID-19 in October. This latest EUA applies to patients with either suspected or confirmed COVID-19, including: While remdesivir needs to be administered intravenously, baricitinib is taken as an oral tablet. The latter is ajanus kinase (JAK) inhibitor, a type of drug that blocks the response of enzymes which cause inflammation and autoimmunity....

Key TakeawaysThe FDA has authorized REGEN-COV to help prevent severe COVID-19 in high-risk people who have been exposed to the virus.The treatment can be delivered via IV infusion or injection.Only those over the age of 12 who are at least 88 pounds can use the treatment. Key Takeaways The FDA has authorized REGEN-COV to help prevent severe COVID-19 in high-risk people who have been exposed to the virus.The treatment can be delivered via IV infusion or injection....

Key Takeaways Late on Thursday evening, the Food and Drug Administration (FDA) authorized booster doses of COVID-19 vaccines from Pfizer-BioNTech and Moderna, specifically for people who are immunocompromised. The shot, which would be a third dose, can be administered as soon as 28 days after the two-dose regimen of the same vaccine. In astatementreleased on Thursday night, acting FDA commissionerJanet Woodcockexplained the agency’s decision: “The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease… people who are immunocompromised…have a reduced ability to fight infections and other diseases, and they are especially vulnerable to infections, including COVID-19....

Key TakeawaysFDA authorized Pfizer and Moderna COVID-19 vaccines for children 6 months and older.Experts say it’s important to have the vaccine options available to young kids, especially those who are most vulnerable to COVID-19. Key Takeaways FDA authorized Pfizer and Moderna COVID-19 vaccines for children 6 months and older.Experts say it’s important to have the vaccine options available to young kids, especially those who are most vulnerable to COVID-19. The Food and Drug Administration (FDA) on Friday authorized the Pfizer and Moderna COVID-19 vaccines for emergency use in children as young as 6 months, more than a year after authorizing the shots for adults....

Key Takeaways For the first time, a breathalyzer can be used to help diagnose COVID-19. And it delivers results in less than three minutes. The Food and Drug Administration (FDA) on Thursday grantedemergency use authorizationto the device, called the InspectIR COVID-19 Breathalyzer, for people 18 and older. Is a Coronavirus Breathalyzer Test Possible? How Accurate Is It? A study of 2,400 people with and without COVID-19 symptoms found that the breathalyzer correctly identified roughly 91% of positive cases....

Key TakeawaysThe U.S. Food & Drug Administration (FDA) approved the first direct-to-consumer coronavirus testing system on December 9.The testing kit will not require a prescription and will be available to individuals 18 years and older.The FDA says the kits are intended to help individuals gain information about possible COVID-19 infection and determine if self-isolation (quarantine) is necessary and/or readily make a plan for healthcare decisions. Key Takeaways The U.S. Food & Drug Administration (FDA) approved the first direct-to-consumer coronavirus testing system on December 9....

Key TakeawaysThe FDA has authorized a point-of-care antibody test for COVID-19 that can be administered in a provider’s office, hospital, or urgent care center.The test only requires a drop of blood.Results are available in just 15 minutes. Key Takeaways The FDA has authorized a point-of-care antibody test for COVID-19 that can be administered in a provider’s office, hospital, or urgent care center.The test only requires a drop of blood.Results are available in just 15 minutes....

Key TakeawaysThe FDA recently approved a new blood test that detects neutralizing antibodies that can block SARS-CoV-2 from entering and infecting human cells.The test will be easier for scientists to use as it doesn’t require using a live virus sample or highly-specialized lab equipment, and it can return results in one to two hours.Studying neutralizing antibodies could help assess future vaccine candidates and determine if a booster-type vaccine will be needed down the road....

Key Takeaways “The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” acting FDA CommissionerJanet Woodcock, MD,said in astatement. This marks the third authorization of a COVID-19 vaccine in the U.S. and the first authorization of a single-dose vaccine. The distribution of millions of doses of the vaccine could begin as early as this week....

Key Takeaways “With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” FDA Commissioner Stephen M. Hahn, MD, said in a statement. An advisory panel to the FDA voted Thursday to recommend that Moderna’s vaccine be authorized. The panel, called the Vaccines and Related Biological Products Advisory Committee (VRBPAC), voted 20 in favor of the recommendation, with one abstention....