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The drug, from Sarepta Therapeutics, promises to repair the defective gene at the root of the fatal disorder, but is expected to cost millions of dollars. → Read More
The FDA tells drugmakers to update their vaccines for fall to take aim at the widespread strain specifically. → Read More
The agency said it would allow Qilu Pharmaceutical to ship into the U.S. a chemotherapy injection known as cisplatin, even though the product hasn’t been FDA approved and the vials are labeled in Chinese. → Read More
Some people have turned to pharmacies to make a solution containing the active ingredient, semaglutide. → Read More
Health authorities and vaccine makers are moving toward targeting the next shot on a form of the XBB strain that is now circulating widely in the U.S. → Read More
The agency is investigating whether any formula manufacturers coordinated before bidding for state contracts. → Read More
The Justice Department is investigating conduct at the Abbott Laboratories infant-formula plant in Sturgis, Mich., that led to its shutdown last year and... → Read More
The debate over medication abortions draws in the lone U.S. manufacturer of brand-name mifepristone. → Read More
Such a move by the Food and Drug Administration could be an important step in the effort to ease the shortage of human donor organs. → Read More
The last doses of the drug, one of a few found to reduce the risk of severe disease even after Omicron, will be used up in late August unless Congress approves more pandemic funding, administration officials say. → Read More
The sign-off is the final step in allowing the shots to become widely available. → Read More
Advisers to the Centers for Disease Control and Prevention backed use of Moderna Inc.’s Covid-19 vaccine in children ages 6 to 17 years. → Read More
Vaccine experts advising the Centers for Disease Control and Prevention voted to recommend Covid-19 shots for young children ages 6 months to 5 years, who could potentially start receiving shots as soon as Monday. → Read More
New variants have weakened the protection of the current shots, which require unpopular boosters. Scientists and the White House are exploring options for more durable protection, but success could take years. → Read More
A recommendation from the advisers, who are meeting Friday and Saturday to review data around vaccinating those under 5 years old, could pave the way for expanding access to the shots. → Read More
Lawmakers are proposing giving the Food and Drug Administration added authority to make sure drugmakers conduct large follow-up studies of fast-tracked therapies → Read More
The outside panel of experts will vote on whether the shot should be authorized, after the agency found it effective but flagged a safety concern. → Read More
The vaccine was 90% effective, but the testing took place before Omicron, and five people who got the shots in studies had complications, the agency said. → Read More
Robert Califf also told lawmakers he expects a surplus of formula in about two months as a result of government and company efforts. → Read More
Officials from the FDA and from the major formula manufacturers are expected to testify before the House Energy and Commerce Committee’s oversight and investigations subcommittee about their attempts to address the short supply. → Read More