GE HealthCare (Nasdaq: GEHC) today announced the U.S. Food and Drug Administration (FDA) has approved a pediatric indication ...

The FDA granted Priority Review to lenacapavir for the prevention of HIV as pre-exposure prophylaxis (PrEP). Lenacapavir is a long-acting HIV-1 capsid inhibitor administered as a twice-yearly ...

On May 8, the Food and Drug Administration granted accelerated approval to the combination of avutometinib and defactinib for ...

Nipocalimab (Imaavy; Johnson & Johnson), an FcRn-blocking monoclonal antibody, was approved for patients 12 years and older ...

The Ethics and Public Policy Center report on mifepristone has earned headlines on the right, but what does the data show?

In a phase 3 trial, 81% of wounds treated with autologous cell sheet-based gene therapy showed ≥ 50% healing at 6 months, ...

The FDA extended aficamten's review by three months for REMS safety program finalization, causing Cytokinetics' stock to drop ...

The U.S. Food and Drug Administration has approved three new color additives from natural sources “that will expand the ...

FDA approves the first treatment for KRAS-mutated ... The RAMP-201 trial (NCT04625270) is an open-label multicenter trial that included 57 adult patients with measurable KRAS-mutated recurrent ...

On the FDA’s docket this month are two expansion bids, one for GSK’s asthma drug Nucala into COPD and another for Merck’s ...

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...

The FDA and CDC have also recommended pausing the use of Ixchiq in seniors 60 years and older while safety investigations are ...