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 ...

Moderna has tapped Swedish long-acting drug formulation company Nanexa to improve the delivery of up to five injectable ...

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.

Targets readouts from nine ongoing Phase 2 and Phase 3 clinical studies in its oncology pipeline, including three Phase 3 programs for intismeran autogene Further improves 2026 and 2027 expected GAAP ...

Moderna told investors that it still thinks it can stop losing money in 2028, and that its financial outlook remains strong, but that it had taken out a $1.5 billion loan to shore up its balance sheet ...

In a large-scale trial, modRNA was significantly better at preventing confirmed flu cases than a typical seasonal flu shot. Reading time 3 minutes Next-generation vaccines could make the flu season ...