Restricted availability under an FDA-mandated drug safety program has limited the reach of CAR-T cell therapies for certain blood cancers—until now. | The FDA has removed the REMS requirements for ...

An FDA study of 110 melatonin supplements marketed for children found doses ranged from 0 to 667 percent of the amount on the ...

Mike Davis previously worked as clinical team leader at the FDA’s Division of Psychiatry before serving as chief medical ...

The label update for Amyvid adds guidance for assessing amyloid plaque levels and may help inform diagnostic and treatment ...

The FDA didn’t routinely test the medications for quality problems or use its vast repository of drug-related complaints to ...

The US Food and Drug Administration (FDA) has approved dupilumab (Dupixent) as the first targeted therapy for bullous ...

Expanded indication builds on existing U.S. FDA approval of mRESVIA for adults aged 60 and older CAMBRIDGE, MA / ACCESS Newswire / June 12, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the ...

A drug called lenacapavir, administered in two injections a year, offers protection from HIV comparable to daily pills. One ...

Daraxonrasib has received breakthrough therapy designation from the FDA for KRAS G12+, previously treated, metastatic ...

The US Food and Drug Administration has approved lenacapavir (Yeztugo), the first twice-yearly injectable HIV-1 prevention ...

The cell-grown fish from Wildtype, which will be available in a fine-dining restaurant, marks the first time cultivated ...

"In our opinion, it's the best tool yet in helping end the HIV epidemic for everyone, everywhere." Others agree. In 2024, Science hailed lenacapavir as its " Breakthrough of the Year " in 2024.