Lilly says it will push ahead on Alzheimer’s drug
The push by Eli Lilly and Co. will come despite an unfavorable ruling last week from Medicare that sharply restricts reimbursements for a drug in the same class.
FDA
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FDA approves another Pfizer, Moderna COVID booster for those 50 and up
The latest expansion, regardless of people’s health, allows an extra shot to millions more Americans—and the question is whether everyone who’s eligible should rush out and get it.
FDA skeptical of benefits from experimental ALS drug
On Wednesday, a panel of FDA advisers will take a non-binding vote on whether the drug warrants approval. The meeting is being closely watched as an indicator of the FDA’s approach to experimental drugs with imperfect data and its ability to withstand outside pressure.
Pressured by patients, FDA reviews ALS drug with modest data
Experts who study FDA decision-making see a troubling pattern in which the beleaguered agency is continually pressured to accept weaker evidence, damaging its scientific credibility and opening the door to ineffective treatments.
FDA expected to sharply restrict use of monoclonal antibodies made by Lilly, Regeneron
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.
Purdue-based startup gets FDA approval for cancer-targeting drug
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.
FDA approves COVID boosters to all adults; final hurdle ahead
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.
FDA panel backs Pfizer’s low-dose COVID-19 vaccine for children
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.
FDA OKs mixing COVID vaccines; backs Moderna, J&J boosters
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.
FDA panel endorses booster shot for J&J COVID-19 vaccine
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.
FDA authorizes first e-cigarette, cites benefit for smokers
The Food and Drug Administration said the vaping device from R.J. Reynolds can help smokers cut back on conventional cigarettes.
FDA review finds Moderna booster strengthens COVID-fighting response
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.
Next on FDA’s agenda: Booster shots of Moderna, J&J vaccines
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.
Big drop in teen vaping seen with COVID-19 school closures
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.
In emphatic vote, FDA panel rejects widespread Pfizer booster shots
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.
Pfizer seeking FDA OK for COVID-19 vaccine booster dose
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.
Pfizer COVID-19 vaccine receives full approval from FDA
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.”
Extra COVID vaccine OK’d for those with weak immune systems
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.
After uproar over FDA’s handling of Biogen Alzheimer’s drug, Lilly presses on
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.
UPDATE: Lilly to seek FDA approval for potential Alzheimer’s drug
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.