In one of the first major tests of the new FDA leadership’s regulatory philosophy toward gene therapies for rare diseases, ...

The FDA is investigating the deaths of two boys with Duchenne muscular dystrophy who died soon after being treated with ...

Tri-Union Frozen Products, also known as Chicken of the Sea Frozen Foods, issued a voluntary recall for its "Raw P&D Tail-On White Shrimp" due to "undeclared sulfites" on May 6. The FDA designated it ...

Several ready-to-eat chicken fettuccine alfredo meals sold at Kroger and Walmart are being voluntarily recalled due to a ...

Curay, the acting director of the FDA’s Center for Drug Evaluation and Research, internally announced her retirement Monday.

The FDA is investigating two deaths in non-ambulatory Duchenne muscular dystrophy patients who received a Sarepta gene ...

ProPublica spent 14 months investigating the FDA’s oversight of foreign drugmakers that send medications to the U.S. These ...

Califf completed his second term as FDA commissioner in January with the change in administrations. He’s only the second ...

A sutureless device for peripheral nerve repair by medical technology company Tissium, which has its US office in Cambridge, ...

The Supreme Court is siding with e-cigarette companies in a ruling that'll make it easier to sue over Food and Drug ...

Rachel's Ginger Beer issued a voluntary recall for its "Cucumber x Tarragon Ginger Beer" in November last year due to ...

The U.S. Food and Drug Administration said on Tuesday that it is investigating reports of two deaths due to acute liver ...