Imricor Medical Systems’ (ASX:IMR) second-generation Vision-MR Ablation Catheter is the device involved in the company’s ...

Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing the tuspetinib (TUS)-based triple drug frontline therapy to treat ...

Alvotech and Teva Pharmaceuticals announced the US Food and Drug Administration (FDA) has accepted for review a Biologics ...

Insulin-aspart-szjj is the first rapid-acting insulin biosimilar approved and the third insulin product approved by the FDA.

Home testing firm LetsGetChecked announced on Tuesday that its ImPress lancing device has received 510(k) clearance from the US Food and Drug Administration for professional use. The single-use blood ...

Incorporating heavy workout routines, strict diets, and taking countless pills can be tiring and not an optimal choice for ...

The U.S. Food and Drug Administration has approved a new drug application for a tablet version of Evrysdi (risdiplam) for ...

So far, five biosimilars that reference Eylea 2 mg have been approved by the FDA. Alvotech/Teva expect to regulatory approval ...

The FDA on Wednesday approved the industry’s first-ever tablet treatment for spinal muscular atrophy— Roche ’s SMN2 splicing ...

U.S.-based PleoPharma announced yesterday that the FDA has granted it a fast-track designation for PP-01, a new ...

A seasoned FDA compliance and regulations expert says you can watch for these major ways health intelligence may change for ...

Evolus said the Food and Drug Administration approved its injectable hyaluronic acid gels, known as Evolysse Form and Evolysse Smooth, in line with management expectations.