South Korea’s Ministry of Food and Drug Safety cleared Acryl Inc.’s Acryl-D01 as the country’s first AI-based digital ...

With Alhemo (concizumab-mtci) from Novo Nordisk A/S, a third hemophilia drug in the past eight months has been approved by the U.S. FDA. The once-daily injectable prophylaxis is to prevent or reduce ...

In the 1970s, scientists from several countries proposed to reconstruct, one by one, all the neurons in the brain as they appear under an electron microscope. They started with a small worm.

The U.S. FDA’s authority was challenged on a number of occasions over the past few decades, but the rate is likely to pick up as the U.S. Supreme Court ruled recently that the agency cannot take ...

The BioWorld Biopharmaceutical Index (BBI) closed November with a modest 3.58% gain for the year, a sharp decline from its 16 ...

Bioarctic AB has entered into a global exclusive license agreement with Bristol Myers Squibb Co. for Bioarctic’s ...

Ionis Pharmaceuticals Inc. CEO Brett Monia predicted that diagnoses of familial chylomicronemia syndrome (FCS) will ...

Merck & Co. Inc. and Hansoh Pharmaceutical Group Co. Ltd. have entered into an exclusive global license agreement for ...

Smith & Nephew plc received U.S. FDA 510(k) clearance for Aetos Stemless, its stemless anatomic total shoulder implant. The ...

A spate of year-end collaborations highlights growing enthusiasm for expanding use of automated insulin delivery devices or ...

Arbor Biotechnologies Inc. has gained IND clearance from the FDA for ABO-101, a novel gene editing therapeutic designed to ...

The end of the year will be the end of an era at the FDA, as Bob Temple shuts his door at CDER for the last time Dec. 31.