The FDA is reportedly considering the addition of high-level warning labels to COVID vaccines, a move that some experts say ...

The decision applies to adolescents and adults and aligns with earlier US authorization for higher-risk groups.

The U.S. Food and Drug Administration intends to put a "black box" warning on COVID-19 vaccines, CNN reported on Friday, ...

An expert panel of the EU drug regulator, the European Medicines Agency (EMA), endorsed seven new medicines for approval this ...

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans.

Study points to source of "very, very rare" cases of myocarditis and potential solutions. Myocarditis risk remains far higher ...

The vaccines were found to decrease the risk of needing medical care in the first six months after vaccination by 76 percent ...

Dr. Vinay Prasad, the director of the FDA's vaccine division, did not provide data to back the claim in a memo sent to staff.

Moderna, an mRNA specialist known for its COVID-19 vaccine Spikevax, is winding down development of three clinical mRNA programs, including two investigational vaccines for infectious diseases. The ...

Moderna shares rose after the company posted a narrower third-quarter loss than Wall Street expected, a sign that its cost-cutting measures are helping offset the decline of its COVID business. The ...

Moderna MRNA-7.01%decrease; red down pointing triangle swung to a loss and logged lower sales in the third quarter as it works to expand its offerings amid weakening demand for its Covid-19 vaccine.

Moderna surged on reports of talks with a large biopharma for a potential partnership or buyout, despite trading at multi-year lows. MRNA's promising cancer vaccine data and surprising findings on ...