J&J (JNJ) and Merck (MRK) announce the acquisitions of private biotechs. The FDA grants Priority Review tags to Sanofi's (SNY) and Roche's (RHHBY) regulatory applications.
The FDA grants priority review to Roche's (RHHBY) NDA for the inavolisib combination regimen for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation.
SOUTH SAN FRANCISCO, Calif., May 29, 2024--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application and granted Priority Review to inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance®) and fulvestrant. The inavolisib-based regimen was evaluated in adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth fa