FDA

The FDA has given Qilu Pharmaceutical permission to ship cisplatin to the U.S. to ease a national cancer drug shortage.

The implant, which Neuralink calls the “Link,” aims to help patients with severe paralysis control external technologies using only neural signals.

Federal health advisers are recommending that a decades-old birth control pill be sold without a prescription. The positive vote on Wednesday by a Food and Drug Administration panel paves the way for what could be the first birth control pill available over the counter. The recommendation is not binding and the FDA is expected to make its decision on the...

U.S. health officials on Wednesday approved the first pill made from healthy bacteria found in human waste to fight dangerous gut infections — an easier way of performing so-called fecal transplants.

Medicare has severely restricted access to the medication Leqembi, which costs $26,500 per year, because the FDA approved it just on an expedited basis.

U.S. health regulators have approved a first-of-a-kind drug for a rare form of Lou Gehrig’s disease.

A federal appeals court late on Wednesday blocked part of a ruling issued last week by a Trump-appointed judge that endangers access to the abortion pill mifepristone.

The Food and Drug Administration is ordering an unproven drug intended to prevent premature births off the market.

The Food and Drug Administration says it found a host of problems at an Indian manufacturing plant recently linked to contaminated eyedrops.

The U.S. Food and Drug Administration has approved selling overdose antidote naloxone over-the-counter, marking the first time a opioid treatment drug will be available without a prescription.

All U.S. women getting mammograms will soon receive information about their breast density, which can sometimes make cancer harder to spot.

U.S. health officials are alerting consumers about two more recalls of eyedrops due to contamination risks that could lead to vision problems and serious injury.

The Food and Drug Administration on Friday approved the first combination test for flu and COVID-19 that can be used at home, giving consumers an easy way to determine if a runny nose is caused by either disease.

Draft U.S. rules would allow soy, oat, almond and other drinks that bill themselves as “milk” to keep using the name.

The single-dose RSV vaccine developed by Pfizer is administered to expectant mothers in the late second-to-third trimester of their pregnancy.

U.S. health officials say a company is recalling its over-the-counter eye drops that have been linked to an outbreak of drug-resistant infections.

The U.S. plans to make it easier for gay and bisexual men to give blood by easing restrictions on groups that typically face higher risks of HIV.

More than 1.6 million people in the U.S. are allergic to sesame, some so severe that they need injections of epinephrine, a drug used to treat life-threatening reactions

The Biogen company wanted to set an “unjustifiably high” initial price of $56,000 a year for the Alzheimer’s drug, investigators said.

The FDA approved the new diabetes treatment Tzield, an injectable treatment that can slow the progression of Type 1 diabetes in patients with stage 2 and delay the need for injectable insulin by two years.