FDA grants Breakthrough Therapy Designation to the company's drug for a rare, fatal pediatric disorder, paving the way for accelerated review and potential approval.
Shares surged in after-hours trading after the company revealed positive results for its lead drug candidate, Telomir-1, in age-related studies.
Nimacimab monotherapy misses primary weight-loss endpoint, though combination with semaglutide shows promise, raising questions for the drug's future.
FDA grants Breakthrough Therapy status for a promising new drug targeting the rare and fatal Sanfilippo Syndrome Type B.
The biotech firm secured its sixth approval for the ZORYVE franchise, expanding its dermatology treatment to children as young as two.
The marketing application for AVT23, a biosimilar to the multi-billion dollar asthma drug Xolair, marks a key regulatory step for Alvotech in the European market.
First patients implanted with the novel neurostimulator marks a key step in challenging market leader Inspire Medical after recent FDA approval.
The designation for ALTO-101 targets cognitive impairment, a debilitating condition with no currently approved treatments, signaling a major regulatory milestone.