Fraiser Kansteiner

With its latest trial readout for under-the-skin efgartigimod, argenx is adding another feather to the FcRn blocker's cap.

After investors blanched last month at a slower-than-expected launch timeline for Celcuity's novel breast cancer med Revtorpyk, the company used much of its latest earnings call to address concerns over—and reaffirm confidence in—the pace of its expected rollout.

After receiving a checkered regulatory scorecard in 2024, Aurobindo's sterile injectables and oncology unit is back in the FDA's crosshairs.

The summer of the high-potency active pharmaceutical ingredient (HPAPI) expansion continues, as yet another manufacturing specialist makes inroads to boost capacity for the sensitive and in-demand drug ingredients.

If at first you don't succeed in gene therapy, then try, try again. That's the lesson Ultragenyx likely took home this week as it pocketed its first

B. Braun Medical—a maker of IV solutions for hospitals, among other products—has initiated a recall in the United States and Canada spurred by particulate contamination.

Less than a year after the FDA turned down the resubmitted application for the company's leukemia prospect Dasynoc, Xspray Pharma has again hit a wall at the U.S. regulator.

Earnings calls are a chance to catch up with the latest developments across Big Pharma and beyond, and last quarter was no different.

Almost three years into his tenure as Lundbeck’s CEO, Charl van Zyl is confident the company can prove its mettle as a “neuroscience challenger” capable of “punching above its weight.”

With its ascent seemingly unstoppable in the last few years, automated cell therapy manufacturer Cellares is facing some tough new realities.