Key Takeaways The U.S. Food and Drug Administration gave full approval to Moderna’s COVID shot for kids ages 6 months to 11 ...

The FDA told Capricor in a letter that it is unable to approve its application for Deramiocel in its current form as it does ...

FDA head Marty Makary said the agency may fast-track drugs from companies that “equalize” the cost of medicines between the U ...

Supplements are part of the daily routine for over half of adults in the United States. However, they aren't regulated in the same way that medications are, so it’s important to be aware of possible ...

The FDA has approved Zegfrovy (sunvozertinib) for locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.

It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...

HealthDay News — The US Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as replies to drug and biological product applications submitted ...