The U.S. Senate votes 52-48 to confirm vaccine skeptic Robert F. Kennedy Jr. to serve as the next HHS secretary.
Researchers in China say they found several new adverse event signals in their review of 20 years of FDA adverse event reports on the antidepressant t...
The Department of Justice has requested information from Inspire Medical as part of a civil probe into its marketing, promotion, and reimbursement pra...
FDA clarifies its enforcement discretion timeframes for compounded tirzepatide.
FDA approves a Genentech NDA for a new tablet formulation of Evrysdi (risdiplam) for treating people with spinal muscular atrophy.
Travere Therapeutics says it will submit an sNDA to FDA for a new indication for its Filspari to treat focal segmental glomerulosclerosis.
FDA approves a Pfizer supplemental BLA for Adcetris (brentuximab vedotin) in combination with lenalidomide and rituximab for treating certain adult pa...
FDA warns Healdsburg, CA-based ISOThrive about failing to submit an IND for two clinical trials it sponsored of an investigational drug.
