Tag Archives: FDA

CNN reports: Pfizer and BioNTech said Friday that the US Food and Drug Administration has granted priority review designation to their application for full approval of their Covid-19 vaccine, and an FDA official said the decision will come “soon”. The FDA official told CNN on Friday that a decision on full approval is likely to come within two months. The …

The Washington Post reports: The Food and Drug Administration on Thursday limited the recommended use of a controversial new Alzheimer’s drug to patients with mild cognitive impairment or early dementia from the disease — a major change from the original label that included everyone with the illness. The revised label clarifies that the drug, called Aduhelm, is intended for patients …

The New York Times reports: The U.S. government spent more than $18 billion last year funding drugmakers to make a Covid vaccine, an effort that lead to at least five highly effective shots in record time. Now it’s pouring more than $3 billion on a neglected area of research: developing pills to fight the virus early in the course of …

CNBC reports: The Food and Drug Administration on Monday approved Biogen Alzheimer’s drug aducanumab, making it the first drug cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades. The FDA’s decision was highly anticipated. The drug, which is marketed under the name Aduhelm, is …

CNBC reports: The Food and Drug Administration approved Pfizer and BioNTech’s request to allow their Covid-19 vaccine to be given to kids ages 12 to 15 on an emergency use basis, allowing states to get middle school students vaccinated before the fall. The U.S. agency granting use of the shot in adolescents will also accelerate the nation’s efforts to drive …

CNBC reports: Pfizer and partner BioNTech said they have started the process of seeking full approval for their Covid vaccine for use in people 16 and older in the U.S., making the companies the first in the nation to file for full regulatory approval. The Food and Drug Administration granted emergency authorization of their Covid vaccine in late December. Since …

The New York Times reports: The Food and Drug Administration is preparing to authorize use of the Pfizer-BioNTech Covid-19 vaccine in adolescents 12 to 15 years old by early next week, according to federal officials familiar with the agency’s plans, opening up the nation’s vaccination campaign to millions more Americans. The news is highly anticipated: Eager parents have been counting …

NBC News reports: The Food and Drug Administration announced Thursday it will begin the process of banning menthol tobacco cigarettes, as well as all flavored cigars — a move heralded as one expected to improve the health of groups most likely to smoke menthol products, including children and Black Americans. “With these actions, the FDA will help significantly reduce youth …

NBC News reports: The Biden administration is expected to announce this week that it will propose a ban on menthol cigarettes, an action urgently sought by tobacco opponents and civil rights groups that say African Americans have been disproportionately hurt by the industry’s aggressive targeting of Black communities. The administration also is poised to say it will seek to ban …

ABC News reports: Women seeking an abortion pill will not be required to visit a doctor’s office or clinic during the COVID-19 pandemic, U.S. health officials said Tuesday in the latest reversal in an ongoing legal battle over the medication. The Food and Drug Administration announced the policy change a day earlier in a letter to the American College of …

The New York Times reports: The Food and Drug Administration on Saturday authorized Johnson & Johnson’s single-shot Covid-19 vaccine for emergency use, beginning the rollout of millions of doses of a third effective vaccine that could reach Americans by early next week. The announcement arrived at a critical moment, as the steep decline in coronavirus cases seems to have plateaued …

NBC News reports: An independent advisory panel to the Food and Drug Administration voted Friday to recommend that the agency authorize Johnson & Johnson’s Covid-19 vaccine. Members of the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, voted unanimously in favor of recommending authorization. The FDA is not required to go along with the committee’s recommendation, but is widely …

Via press release from the FDA: Today, the U.S. Food and Drug Administration announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks. This reflects an alternative to the preferred storage of the undiluted vials in …

Via press release from the FDA: We have been following the discussions and news reports about reducing the number of doses, extending the length of time between doses, changing the dose (half-dose), or mixing and matching vaccines in order to immunize more people against COVID-19. These are all reasonable questions to consider and evaluate in clinical trials. However, at this …

Via press release from the FDA: On December 30, 2020, Midwestern Pet Food, Inc. announced a recall of certain lots of Sportmix pet food products after FDA was alerted about reports of at least 28 dogs that have died and eight that have fallen ill after consuming the recalled Sportmix pet food. Multiple product samples were tested by the Missouri …

CNBC reports: An influential Food and Drug Administration advisory panel on Thursday overwhelmingly backed Moderna’s coronavirus vaccine, a key step paving the way to distribute the second Covid-19 vaccine in the United States next week. An emergency use authorization means the FDA will allow some people to receive the vaccine as the agency continues to evaluate data. It isn’t the …

Via press release from the FDA: Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects …

The Wall Street Journal reports: The Food and Drug Administration said Tuesday that the Covid-19 vaccine developed by Moderna is “highly effective,” suggesting the vaccine could soon be added to the arsenal against the pandemic. Moderna’s documents posted by the FDA included new data suggesting that its vaccine begins to prevent asymptomatic infections after the first dose. The ability of …

ABC News reports: In an interview with Fox News Saturday, Trump, after seeming to take credit for the speed of the vaccine’s development, said that the Food and Drug Administration could have authorized the shot for emergency use “last week.” “They could have even done it a week sooner,” the president continued. “We do not feel that this could have …

CNBC reports: The Food and Drug Administration has approved Pfizer and BioNTech’s coronavirus vaccine for emergency use, a monumental turning point in the once-in-a-century pandemic that has taken nearly 300,000 American lives in less than a year and wreaked havoc on the U.S. economy. FDA Chief Scientist Denise Hinton told Pfizer in a letter Friday that she was authorizing the …