GlaxoSmithKline said U.S. health authorities asked for more information about the company’s Nucala drug for use in combating chronic obstructive pulmonary disease (COPD).
The FDA approved Merz Neurosciences’ supplemental Biologics License Application for Xeomin (incobotulinumtoxinA), a treatment for chronic drooling in adults with neurodegenerative diseases.
The FDA granted Genentech’s Tecentriq triple combination with Avastain, paclitaxel and carboplatin Priority Review for the first-line treatment of patients with metastatic NSCLC.
Shire plc announced the U.S. Food and Drug Administration accepted the Biologics License Application and granted priority review for lanadelumab (SHP643).
The biopharma industry and the U.S. Food and Drug Administration face a busy December with nine companies awaiting approval decisions.
The U.S. regulatory agency approved Genentech’s Gazyva for patients with previously untreated advanced follicular lymphoma.
The FDA accepted for filing Seattle Genetics’ supplemental Biologics License Application for Adcetris in patients with cutaneous T-cell lymphoma.
The U.S. FDA accepted for review the Biologics License Application (BLA) for ibalizumab as a treatment for multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1).
In light of a rejection from the U.S. FDA, Coherus Biosciences disclosed to the U.S. SEC that it plans to pink-slip 30 percent of its staff.
Kite Pharma announced that the U.S. FDA accepted for priority review the BLA for axicabtagene ciloleucel for refractory aggressive non-Hodgkin lymphoma (NHL).