Epidemics
FDA withdraws Covid antibody treatment Evusheld because it’s not effective against 93% of subvariants
Evusheld (tixagevimab and cilgavimab) injection, a new COVID-19 treatment that people can take before becoming symptomatic. (Chris Sweda/Chicago Tribune/Tribune News Service via Getty Images) Chris Sweda | Tribune News Service | Getty Images The Food and Drug Administration on Thursday pulled its authorization for AstraZeneca‘s Evusheld, an antibody injection that people with weak immune systems […]
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FDA advisors recommend replacing original Covid vaccine with bivalent omicron shots for all doses
The Food and Drug Administration’s independent advisory committee on Thursday recommended replacing Pfizer and Moderna’s original Covid vaccine used in the U.S. for everyone’s first two immunizations with the new bivalent omicron shots. If the FDA accepts the advisors’ recommendation, the U.S. would likely phase out the companies’ vaccines developed in 2020 against the original […]
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FDA doesn’t see increased risk of stroke for seniors who received Pfizer’s omicron booster
A nurses fills up syringes for patients as they receive their coronavirus disease (COVID-19) booster vaccination during a Pfizer-BioNTech vaccination clinic in Southfield, Michigan, September 29, 2021. Emily Elconin | Reuters The Food and Drug Administration hasn’t found an increased risk of stroke for seniors who’ve received Pfizer’s omicron booster shot, a federal health official […]
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Omicron booster shots provide some protection against mild illness from Covid XBB subvariants, CDC says
Pfizer‘s and Moderna‘s omicron boosters reduced the risk of mild illness from the XBB family of subvariants compared to people who did not receive the shot, according to a study from the Centers for Disease Control and Prevention published Wednesday. The CDC study provides the first estimate of the omicron shots’ real-world effectiveness against the […]
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Abortion pill maker GenBioPro sues West Virginia, argues FDA rules preempt state ban
Abortion pill manufacturer GenBioPro on Wednesday sued to overturn West Virginia’s ban on abortion because it restricts access to a medication approved by the Food and Drug Administration. The lawsuit, filed in federal court in West Virginia’s southern district, argues that FDA regulations on medications such as the abortion pill preempt state law under the […]
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FDA proposes new lead limits for baby food to reduce potential risks to children’s health
Jgi/jamie Grill | Tetra Images | Getty Images The Food and Drug Administration proposed new limits Tuesday on lead in baby food, in an effort to reduce exposure to a toxin that can impair childhood development. The lead limits apply to processed food consumed by children younger than two years old. In a statement, FDA […]
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The FDA’s power to approve drugs faces sweeping challenge in lawsuit seeking to pull abortion pill from U.S. market
Mifepristone (Mifeprex) and Misoprostol, the two drugs used in a medication abortion, are seen at the Women’s Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, New Mexico, on June 17, 2022. Robyn Beck | AFP | Getty Images The Food and Drug Administration is squaring off with anti-abortion physicians in an unprecedented […]
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FDA says Covid vaccines will probably get an annual update but most people will likely need only one shot
Justin Sullivan | Getty Images The Food and Drug Administration has laid out a road map for what Covid-19 vaccination may look like moving forward. In a briefing document published Monday, the FDA said the vaccines will probably need an annual update as the virus continues to evolve. The agency would select the Covid strain […]
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Moderna says RSV vaccine is 84% effective at preventing disease in older adults
A woman receives a booster dose of the Moderna coronavirus disease (COVID-19) vaccine at a vaccination centre in Antwerp, Belgium, February 1, 2022. Johanna Geron | Reuters Moderna on Tuesday said its vaccine targeting respiratory syncytial virus is effective at preventing disease in older adults. The vaccine was 83.7% effective at preventing lower respiratory tract […]
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CDC says it’s ‘very unlikely’ Pfizer booster carries stroke risk for seniors after launching review
The Centers for Disease Control and Prevention on Friday said it is “very unlikely” the Pfizer omicron booster carries a risk of stroke for seniors after it launched an investigation into a preliminary safety concern detected by one of its monitoring systems. The CDC, in a statement posted to its website Friday, said a surveillance system […]
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