FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...

The FDA has determined that REMS programs are no longer necessary to ensure the benefits of these CAR T cell immunotherapies outweigh their risks.

The Food and Drug Administration will consider drug affordability when granting companies new vouchers that speed up approvals of some treatments, the agency's Commissioner Marty Makary told CNBC.

In June 2025, the US Food and Drug Administration (FDA) announced a major update to its General Food Labeling Requirements Compliance Program—the first overhaul of this program since 2010. This ...

FDA employees are spooked by increasing political involvement in regulatory decisions, frustrated by the impact of cuts to administrative staff who supported drug reviews and inspections, and fed ...

On Monday, June 30, 2025, FDA’s Human Food Program published its proposed 2025 guidance agenda (FDA’s news release shown here). The agenda contains possible new topics for guidance documents ...

MRK's regulatory filing for once-daily HIV pill DOR/ISL gets FDA acceptance, with a decision expected by April 2026.

Alcami Corporation ("Alcami"), a leading contract development and manufacturing organization (CDMO), today announced several strategic leadership appointments within its Drug Product team. These ...