Pemgarda has a standing emergency use authorization as a prophylaxis for immunocompromised patients, but FDA’s stringent ...

OTO, is one of several early-stage gene therapies being developed to treat relatively straight-forward causes of genetic ...

The World Health Organization names antimicrobial resistance as one of the most urgent public health threats, but it remains ...

President Trump also refused to promise pharma execs that he would hamstring the IRA’s drug negotiation program.

Drug development powered by artificial intelligence is countering incentives from the Inflation Reduction Act and making ...

Ctexli’s approval further entrenches Mirum as a leader in rare liver diseases, alongside its cornerstone product Livmarli and ...

Around 300 FDA staffers laid off last week are being asked to return. So far, the Trump administration has terminated some ...

Non-opioid pain therapies are entering an unprecedented era, marked by the landmark FDA approval of Vertex’s Journavx and a ...

With the modality now in early clinical trials, experts say more efficiency, broader editing capabilities and delivery ...

Morale is low at the FDA, which was hit with layoffs this week following RFK Jr.’s confirmation. Biopharma leaders and agency ...

The postponed ACIP meeting comes barely a week after Robert F. Kennedy, Jr. was confirmed as Secretary of Health and Human ...

The move comes weeks after Pfizer terminated its partnership with Sangamo Therapeutics for another hemophilia gene therapy.