The company said it was “surprised” by the decision, which followed the ouster of multiple cell and gene therapy officials from the agency during deramiocel’s review.

The sandwiches were available at micro markets and vending machines in all of Ohio, Eastern Indiana and Northern Kentucky.

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 ...

The company expects to make the updated Spikevax available to U.S. patients in time for the 2025-26 respiratory virus season.

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 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 ...