The Food and Drug Administration is poised as soon as Monday to restrict two monoclonal antibodies, saying the COVID-19 treatments should not be employed in any states because they are ineffective against the dominant omicron variant, according to two senior administration health officials.
It’s a big moment for On Target Laboratories, an 11-year-old biotech based in West Lafayette. The FDA approval marks the company’s first novel compound to get across the finish line. The drug is marketed under the brand name Cytalux.
There’s one more step: The Centers for Disease Control and Prevention must agree to expand Pfizer and Moderna boosters to even healthy young adults. Its scientific advisers were set to debate later Friday.
The U.S. moved a step closer to expanding COVID-19 vaccinations for millions more children as government advisers on Tuesday endorsed youth-size doses of Pfizer’s shots for 5- to 11-year-olds.
The Food and Drug Administration’s decisions mark a big step toward expanding the U.S. booster campaign, which began with extra doses of the Pfizer vaccine last month.
U.S. health advisers endorsed a booster of Johnson & Johnson’s COVID-19 vaccine Friday, citing growing worry that Americans who got the single-dose shot aren’t as protected as those given two-dose brands.
The Food and Drug Administration said the vaping device from R.J. Reynolds can help smokers cut back on conventional cigarettes.
On Thursday, advisers are expected to consider data supporting a third shot of Moderna, which would be the equivalent of a half-dose of the original shot. The booster would be administered at least six months after initial vaccination.
On Thursday and Friday, the FDA convenes its independent advisers for the first stage in the process of deciding whether extra doses of the two vaccines should be dispensed and, if so, who should get them and when.
Teen vaping plummeted this year as many U.S. students were forced to learn from home during the pandemic, according to a government report released Thursday.
Over several hours of discussion on Friday, members of the Food and Drug Administration panel of outside experts voiced frustration that Pfizer had provided little data on the safety of extra doses.
Last week, U.S. health officials announced plans to give COVID-19 booster shots to all Americans to shore up their protection amid the surging delta variant of the coronavirus.
The U.S. becomes the first country to fully approve the shot, according to Pfizer, and CEO Albert Bourla said he hoped the decision “will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives.”
The late-night announcement by the Food and Drug Administration applies to several million Americans who are especially vulnerable because of organ transplants, certain cancers or other disorders.
Even as some drugmakers, including Indianapolis-based Eli Lilly and Co., are pushing to get experimental drugs approved, federal regulators are still dealing with a huge blowback over the controversial way they reviewed a new Alzheimer’s drug by rival Biogen.
Eli Lilly and Co. shares jumped more than 9% Thursday morning after it received “breakthrough therapy” designation for donanemab from the U.S. Food and Drug Administration, putting the drug on a path that could expedite its development.
The decision, which could affect millions of older Americans and their families, also has far-reaching implications for the standards used to evaluate experimental therapies, including those that show only incremental benefits.
U.S. health regulators pledged again Thursday to try to ban menthol cigarettes, this time under pressure from African American groups to remove the mint flavor popular among Black smokers.
The FDA has long targeted menthol cigarettes for a regulatory crackdown amid warnings from doctors and other public health experts that the products are easier to start smoking, harder to quit and cause outsize harm to African Americans.
The CDC and FDA said Tuesday they were investigating clots in six women that occurred 6 to 13 days after vaccination.
