Less than three weeks after lifting a pause on the use of Valneva’s chikungunya vaccine Ixchiq, the FDA has done an about-face, banning the use of the shot in the United States.

The company touts a large U.S. market opportunity for scPharmaceuticals’ Furoscix, which recently expanded into chronic kidney disease.

On Monday, Argenx reported that its chief drug Vyvgart met the mark in a phase 3 trial assessing the FcRn blocker in the subset of generalized myasthenia gravis patients who are seronegative. Overall, seronegative patients represent roughly 20% of those with generalized myasthenia gravis, and Argenx’s sought-after nod could significantly […]

BeOne Medicines is monetizing its stake in Amgen’s first-in-class lung cancer drug Imdelltra for up to $950 million.

The U.S. drug regulator has unveiled a plan to dramatically speed up adverse event reporting.

Catalent is laying off 350 employees at its gene therapy manufacturing division in Baltimore “due to an unexpected shift in demand from a large customer, which made it necessary to reduce our workforce,” a spokesperson said.