Tag Archives: FDA

The Washington Post reports: Biden administration officials are set to announce Tuesday a new strategy to split monkeypox vaccine doses in hopes of vaccinating up to five times as many people against the virus, according to officials with direct knowledge of the plan. Rather than inject doses of Jynneos subcutaneously, a traditional way of delivering vaccines into the fatty tissue …

CNBC reports: The U.S. will make 786,000 additional monkeypox vaccine doses available to local health departments “as soon as possible” after the Food and Drug Administration approved the shots for distribution. The Jynneos vaccine is made by the Danish biotech company Bavarian Nordic. The FDA had to inspect and sign off on a Bavarian Nordic plant in Denmark to ensure …

The Associated Press reports: The U.S. government has purchased more than 1.1 million completed doses of the vaccine produced by Bavarian Nordic in Denmark. But the company said earlier this week it needed authorization from an on-site FDA inspection before it could begin sending most of them to the U.S. An FDA spokeswoman said late Wednesday that regulators “expedited and …

CNBC reports: The Food and Drug Administration has authorized Novavax’s two-dose vaccine for adults ages 18 and over, the fourth Covid shot to get emergency approval in the U.S. since the pandemic began. The FDA decision comes weeks after its committee of independent vaccine experts voted overwhelming in favor of Novavax’s shot in early June, after an all-day public meeting …

Axios reports: Pharmaceutical company HRA Pharma submitted an application to the Food and Drug Administration on Monday asking to sell a birth control bill over-the-counter, rather than via prescription. If approved, it would be the first ever birth control pill to be available over-the-counter in the U.S. The application was submitted just weeks after the Supreme Court overturned Roe v. …

Via press release from the FDA: As we move into the fall and winter, it is critical that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most severe consequences of COVID-19. Following a thorough discussion on June 28, 2022, an overwhelming majority of the advisory committee voted in favor …

The New York Times reports: A federal appeals court on Friday granted a temporary reprieve to Juul Labs that will allow it to keep its e-cigarettes on the market, pending further court review of a decision just a day earlier by the Food and Drug Administration to ban sales of the company’s products. It will be up to the appeals …

The New York Times reports: The Food and Drug Administration on Thursday ordered Juul to stop selling e-cigarettes on the U.S. market, a profoundly damaging blow to a once-popular company whose brand was blamed for the teenage vaping crisis. The order affects all of Juul’s products on the U.S. market, the overwhelming source of the company’s sales. Juul’s sleek vaping …

Media Matters has the transcript: Yesterday the FDA announced it’s planning to remove virtually all nicotine from cigarettes. Now nicotine is not the thing that gives you cancer. Nicotine is the thing — it’s addictive but it also increases mental acuity but they’re taking that out. According to the Wall Street Journal, the agency will also ban Juul e-cigarettes. Now …

NBC News reports: The Food and Drug Administration on Friday authorized both Pfizer-BioNTech and Moderna’s Covid-19 vaccines for young children, though the CDC still needs to sign off before shots can be administered. The Pfizer vaccine was authorized for children ages 6 months to 4 years, while the Moderna vaccine was authorized for children ages 6 months to 5 years, …

The Washington Post reports: A panel of independent vaccine experts recommended Tuesday that the Food and Drug Administration authorize a coronavirus vaccine developed by the Maryland biotechnology company Novavax, paving the way for the fourth shot in the United States. The experts’ vote was 21 in favor of authorizing the Novavax vaccine, with one abstention. But it remained unclear when …

The Washington Post reports: A multistate outbreak of hepatitis A infections in the United States and Canada is likely to have been sparked by contaminated organic strawberries sold in leading grocery stores, the Food and Drug Administration warned, urging customers to throw out any uneaten batches that may have been frozen for later consumption. “Consumers, restaurants, and retailers should not …

CNBC reports: Abbott has reached an agreement with the Food and Drug Administration to reopen its manufacturing plant in Michigan to help ease a nationwide shortage of baby formula, the company announced Monday. Abbott said it can restart the Michigan plant within two weeks subject to FDA approval. However, it would take six to eight weeks from the start of …

The Associated Press reports: The U.S. government on Thursday released its long-awaited plan to ban menthol cigarettes and flavored cigars, citing the toll on Black smokers and young people. “The proposed rules would help prevent children from becoming the next generation of smokers and help adult smokers quit,” said HHS Secretary Xavier Becerra, in a statement. He added that the …

Via press release from the CDC: Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection. The test can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals and mobile …

USA Today reports: People age 50 and up are now eligible for a second booster dose of COVID-19 vaccine at least four months after their first, the Food and Drug Administration said Tuesday. “Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk …

Via press release from the FDA: Today, the U.S. Food and Drug Administration authorized the marketing of the first condoms specifically indicated to help reduce transmission of sexually transmitted infections (STIs) during anal intercourse. The condoms, which will be marketed as the One Male Condom, are also indicated as a contraceptive to help reduce the risk of pregnancy and the …

The Washington Post reports: A rodent infestation at a Family Dollar warehouse has prompted the discount store chain to recall a wide range of products sold at hundreds of stores throughout the southern United States. Health concerns about the rat infestation at an Arkansas distribution center have also led to the temporary closure of more than 400 stores in six …

Yahoo News reports: U.S. health regulators are looking at authorizing a potential fourth dose of a COVID-19 vaccine in the fall, the Wall Street Journal reported on Sunday citing sources familiar with the matter. The Food and Drug Administration has been reviewing data to authorize a second booster dose of the messenger RNA vaccines from Pfizer Inc and partner BioNTech …

Via press release from the FDA: Today, the U.S. Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. 1, 2021, through the present from Family Dollar stores in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee may be unsafe for consumers to use. The impacted products originated from the company’s distribution facility in …