After Jenny Pearson’s daughter Elise first had a seizure at 16 months old, an MRI came back clean—her brain “looked beautiful,” Pearson recalled to Fierce. But a follow-up scan a year later, just days before Thanksgiving, showed her frontal lobe was now awash in white splotches. A genetic test the […]

Daiichi Sankyo subsidiary American Regent is launching a recall of three lots of generic epinephrine as it becomes one of the latest manufacturers to face headaches over particulate contamination in its drug products.

In this week’s episode of “The Top Line,” we look at the people who kept working the problem, from scientists pushing past long-standing limits in cancer and protein design to physicians and public health leaders tackling trust, misinformation, vaccine policy and representation in medicine.

The social media collaboration ties into Novartis’ “you know your MS best” messaging, which encourages patients to keep track of changes in their disease.

Following a string of customer complaints, a Form 483 and a recall this past spring, a Fresenius manufacturing unit in Utah is contending with a warning letter from the FDA.

Two votes of confidence from leaders at the FDA’s Office of Clinical Evaluation and the Oncology Center of Excellence sealed Replimune’s fate, overruling review staffers’ concerns and paving the way for last month’s accelerated nod for Tudriqev.