The move gives doctors and high-risk patients an additional option for treating mild-to-moderate illness caused by the coronavirus By Laurie McGinley, January 21, 2022 at 7:20 p.m. EST Federal regulators Friday approved the use of the antiviral drug remdesivir for covid-19 outpatients at high risk of being hospitalized, providing a new treatment option for doctors...
Tag: <span>FDA</span>
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FDA Approves Combo Pill for Severe, Acute Pain
Megan Brooks October 19, 2021 The US Food and Drug Administration (FDA) has approved a combination pill containing celecoxib and tramadol (Seglentis) for the treatment of adults with acute pain severe enough to require an opioid analgesic and for which alternative treatments fail to provide adequate pain relief. Celecoxib is a nonsteroidal anti-inflammatory drug and tramadol is an opioid...
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FDA OKs New Adult Insomnia Med
Erik Greb January 10, 2022 The US Food and Drug Administration (FDA) has approved the dual orexin receptor antagonist daridorexant (Quviviq) for the treatment of insomnia in adults, the drug’s manufacturer, Idorsia, has announced. The FDA’s decision was based partly on a phase 3 trial of adults with moderate-to-severe insomnia who were randomly assigned to receive 25...
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FDA shortens timing of Moderna booster to 5 months
JANUARY 7, 2022 Credit: Pixabay/CC0 Public Domain U.S. regulators on Friday shortened the time that people who received Moderna’s COVID-19 vaccine have to wait for a booster—to five months rather than six. The two-dose Moderna vaccine is open to Americans 18 and older. The Food and Drug Administration’s decision Friday means Moderna recipients are eligible...
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FDA may allow Pfizer boosters for 12- to 15-year-olds by Monday
Younger adolescents may soon be eligible for COVID-19 booster vaccines, possibly by early next week. The U.S. Food and Drug Administration is planning on Monday to broaden booster eligibility to include 12- to 15-year-olds, sources told The New York Times. This would be for the Pfizer-BioNTech shot, currently the only COVID-19 vaccine approved for this age group. The...
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FDA issues emergency use authorization for second at-home COVID-19 treatment
by Mayo Clinic Credit: Pixabay/CC0 Public Domain For the second time in as many days, the Food and Drug Administration (FDA) has granted emergency use authorization for an investigational antiviral pill to treat COVID-19. This time it is Merck’s molnupiravir. According to the company, under the emergency use authorization, the treatment is cleared to treat mild...
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FDA allows abortion pill to stay available by mail
(HealthDay)—Access to abortion pills by mail was made permanent by the U.S. Food and Drug Administration on Thursday. Patients will be able to have a telemedicine appointment with a provider who can prescribe the pills and send them to the patient by mail, the FDA said in new guidance issued Thursday. Abortion pills are approved in the...
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AbbVie’s age-related blurry vision drug for aging adults was given the OK by the FDA Friday
Josh SullivanAssociate Editor AbbVie’s age-related blurry vision drug for aging adults was given the OK by the FDA Friday, making it the first eye drop to treat an eye condition that affects 128 million Americans. Formerly AGN-190584, the drug has proven a bright spot in Allergan’s pipeline since AbbVie bought it out for $63 billion,...
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When can you vaccinate your kids? What we know as FDA prepares to consider data from studies
by Erin Digitale, Stanford University Medical Center Credit: Unsplash/CC0 Public Domain On Sept. 20, Pfizer-BioNTech announced that it’s preparing to submit data to the Food and Drug Administration on the initial results of its COVID-19 vaccine study in school-age children. The move signaled a big step toward expected emergency use authorization of the vaccine for kid...
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FDA Approves First COVID-19 Vaccine
Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization...