The move follows years of pressure from medical experts and consumer advocates to make the devices cheaper and easier to get.
HRA Pharma’s application on Monday sets up a high-stakes decision for health regulators amid legal and political battles over women’s reproductive health.
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.
Experts point to decades-old policies that have allowed a handful of companies to corner the infant formula market.
The formula shortage has rattled parents and become a political headwind for President Joe Biden, who’s invoked the Defense Production Act to ease supply.
The FDA granted full approval of Pfizer’s vaccine last August.
The acting head of the Food and Drug Administration on Friday called for a government investigation into highly unusual contacts between some of her agency’s drug reviewers and the maker of a controversial new Alzheimer’s drug.
Thursday’s announcement comes after state officials warned that many doses in storage would expire before the end of the month.
Aduhelm is the only drug that U.S. regulators have said can possibly treat the underlying disease, rather than manage symptoms like anxiety and insomnia.
About 40% of all abortions in the U.S. are now done through medication — rather than surgery — and that option has become more pivotal during the coronavirus pandemic.
The Centers for Disease Control and Prevention and the Food and Drug Administration said they were investigating unusual clots in six women that occurred six to 13 days after vaccination.
Vaccinating children of all ages will be critical to stopping the pandemic — and helping schools start to look a little more normal after months of disruption.
One challenge in rolling out the new vaccine will be explaining how protective the single shot is after the astounding success of the first double-shot vaccines.
The Food and Drug Administration’s scientists confirmed that the vaccine is about 85% effective at preventing severe COVID-19, and it is safe.
A government advisory panel endorsed a second COVID-19 vaccine Thursday, paving the way for the shot to be added to the U.S. vaccination campaign.