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The drug, Leqembi, is the first that’s been convincingly shown to slow the decline in memory and thinking that defines Alzheimer’s by targeting the disease’s underlying biology. → Read More
Tuesday’s action formally updates the drug’s labeling to allow women to get a prescription via telehealth consultation with a health professional, and then receive the pills through the mail, where permitted by law. → Read More
Sound-dampening foam in the pressurized breathing machines can break down over time, leading users to potentially inhale tiny black particles or hazardous chemicals while they sleep, manufacturer Philips warned. → Read More
Pfizer and Moderna already were brewing and testing boosters updated against the first omicron mutant in anticipation of an October rollout. → Read More
The action is part of a sweeping effort by the Food and Drug Administration to bring scientific scrutiny to the multibillion-dollar vaping industry after years of regulatory delays. → Read More
The February shutdown of the largest formula factory in the country led to supply problems. → Read More
FDA Commissioner Robert Califf is set to answer questions Wednesday from House lawmakers probing the events leading to the formula shortage. → Read More
President Joe Biden is offering formula manufacturers and retailers transportation and logistics support to ease the nationwide shortage of baby formula. → Read More
Many parents are hunting for infant formula after a combination of short- and long-term problems hit most of the biggest U.S. brands. → Read More
Under a law taking effect Thursday, the Food and Drug Administration can regulate e-cigarettes and similar products that use synthetic nicotine. → Read More
The action by the Food and Drug Administration means the agency has completed the same rigorous, time-consuming review of Moderna’s shot as dozens of other long-established vaccines. → Read More
The website, COVIDTests.gov, allows people to order four at-home tests per household and have them delivered by mail. But the tests won’t arrive for seven to 12 days. → Read More
The rapidly-spreading omicron variant may soon leave U.S. doctors without two of the standard treatments they’ve used to fight COVID-19. → Read More
Pfizer says that its experimental COVID-19 pill appears effective against the omicron variant. → Read More
On Thursday, the Food and Drug Administration gave emergency authorization for 16- and 17-year-olds to get a third dose of the vaccine made by Pfizer and its partner BioNTech -- if it’s been six months since their last shot. → Read More
The drug could benefit cancer patients, organ transplant recipients and people with severe allergies to vaccinations. → Read More
The Food and Drug Administration is asking its outside experts whether the agency should authorize the pill, weighing new information that it is less effective than first reported and may cause birth defects. → Read More
Pfizer and Moderna announced Friday the Food and Drug Administration’s decision after at least 10 states already had started offering boosters to all adults. → Read More
Pfizer said it will ask the FDA and international regulators to authorize its pill as soon as possible, after independent experts recommended halting the company’s study based on the strength of its results. Once Pfizer applies, the FDA could make a decision within weeks or months. → Read More
Details of the study were posted online Friday as U.S. regulators consider opening vaccinations to youngsters 5 to 11. → Read More