Since its inception in 1992, the FDA’s accelerated approval pathway has helped shepherd nearly 300 new drugs to the market.

The FDA is looking at four events for the remainder of October, one of which is an advisory committee meeting for a dual SGLT ...

As companies roll out data showing the power and improved safety profile of antibodies that target two antigens, analysts say ...

The U.S. Department of Justice alleged that Teva violated the Anti-Kickback Statute and the False Claims Act. The payment is ...

With the regulatory approval for advanced breast cancer, Roche’s inavolisib is a potential challenger to Novartis’ PI3K ...

Senator Elizabeth Warren told the Federal Trade Commission that the acquisition of contract manufacturer Catalent could ...

Oditrasertib, which blocks the inflammatory RIPK1 protein, earlier this year also failed a Phase II trial in amyotrophic ...

Two biotechs set out for the public markets this week, with Upstream Bio raising $255 million for its inflammatory disease ...

Turnstone is shifting resources to focus on clinical advancement of its selected tumor-infiltrating lymphocyte therapy as ...

Despite substantial variability in the presented data and no well-controlled trial, the FDA advisory committee voted in favor ...

Carlos Doti has moved countries and changed jobs, but one thing hasn’t changed. Making an impact on patient care has always ...

The settlement, which is at the low end of Jefferies analysts’ $2 billion to $3.5 billion estimate, will resolve 93% of the ...