FDA

The FDA approved Pfizer and BioNTech’s request to allow their Covid-19 vaccine to be given to kids ages 12 to 15 on an emergency use basis.

Pfizer and BioNTech are the first companies to seek full regulatory approval of Covid vaccines in the U.S.

Peter Pitts, a former FDA associate commissioner in the Bush administration, disagrees with President Joe Biden on suspending vaccine patents. Suspension of the patents might allow for broader distribution of the shots in the world, but Pitts says it could discourage companies from wanting to partner with the government. He would rather see companies like Pfizer sell their vaccine at...

U.S. health regulators are pledging again to try to ban menthol cigarettes.

The Food and Drug Administration announced Thursday it will begin the process of banning menthol tobacco cigarettes in an attempt to improve the health of groups most likely to smoke menthol products.

The FDA’s decision would not ban menthol immediately, but rather kick off the rule-making process to do so, which could take years.

U.S. regulators are convening a meeting to consider clawing back approvals from several cancer drugs that have failed to show they extend or improve life

The U.S. faced shortages for drugs used to treat Covid-19 patients during the pandemic as demand surged but supply.

The Biden administration is considering whether to cap nicotine levels in cigarettes, the Wall Street Journal reported.

Dr. Anne Schuchat, principal deputy director of the CDC, explains what to monitor if you recently received the Johnson & Johnson COVID-19 vaccine.

With a third coronavirus vaccine now approved in the U.S., what is the difference between the vaccines and should you opt for one over the other?

Dr. Peter Marks, Director, FDA Center for Biologics Evaluation and Research, explains why the FDA recommended a pause in the administration of the Johnson & Johnson vaccine despite the appearance of blood clots being so rare.

Gottlieb predicted that the move will nonetheless “fuel the hesitancy” from some people to get a Covid vaccine.

The U.S. is recommending a “pause” in administration of the single-dose Johnson & Johnson COVID-19 vaccine out of “an abundance of caution” to investigate reports of rare, potentially dangerous blood clots.

The request cites an interim analysis of a phase three trial that evaluated the drug for early treatment of Covid in adults at high risk of hospitalization.

The statement comes just one day after the findings of a large U.S. trial showed the Oxford-AstraZeneca vaccine was safe and highly effective.

For nearly 130 years, the brand Wrigley’s has become synonymous with chewing gum. Since 2015, Mars Wrigley has held 25% of the global brand share for chewing gum and a 40% hold in the U.S.

Marlboro parent Altria is asking the Food and Drug Administration to help it spread the word that nicotine doesn’t cause cancer.

This makes the Johnson & Johnson vaccine the third vaccine to have emergency use authorization from the U.S. Food and Drug Administration.

In an expansion of an existing notice, the Connecticut Department of Public Health is warning consumers not to eat any El Abuelito Cheese Company soft cheese products after the items were tied to a multistate Listeria outbreak. The FDA recall now includes all fresh cheese products with expiration dates through March 28, 2021. The items were distributed under the El…