IntraBio Inc., a leader in the discovery, development, and commercialization of novel therapies for rare and common neurodegenerative diseases, today announced that the U.S. Food and Drug ...

Eli Lilly (LLY) on Friday announced that the U.S. FDA granted full approval for an all-oral regimen containing its estrogen receptor antagonist Inluriyo and kinase inhibitor Verzenio as a late-line ...

FDA approves Inluriyo plus Verzenio for adults with ESR1-mutated, ER-positive, HER2-negative advanced or metastatic breast ...

Ultragenyx Pharmaceutical’s Fayuvi is now the first FDA-approved therapy for the underlying cause of Sanfilippo syndrome type ...

The US Food and Drug Administration (FDA) has approved Ultragenyx's gene therapy for Sanfilippo syndrome type A, marking the first treatment of its kind greenlit for children with the genetic ...

The FDA approved combination imlunestrant plus abemaciclib for adults with hormone therapy-resistant estrogen ...

Data from the phase 3 EMBER-3 trial support the full approval of imlunestrant plus abemaciclib in this breast cancer population.

For the first time, patients living with a rare neurological disease have a new treatment option — and the FDA’s decision ...

Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the U.S. Food and Drug Administration (FDA) granted standard full approval of FAYUVI™ (rebisufligene etisparvovec-hopf), also known ...

Fayuvi, previously known as UX111, uses an adeno-associated viral vector to deliver a working copy of the SGSH gene into the patient’s cells. It marks the first FDA-approved therapy designed to ...

Good afternoon, and welcome to the Ultragenyx Pharmaceutical conference call to discuss the U.S. Food and Drug Administration approval of the FAYUVI for the treatment of the MPS IIIA, also known as ...

Shares of Ultragenyx Pharmaceutical climbed after the Food and Drug Administration approved the company's Fayuvi for children with Sanfilippo syndrome type A. The stock closed up 13% at $14.50 ...