The U.S. FDA issued a Complete Response Letter to Netherlands-based Pharming Group for the company’s supplemental Biologics License Application for Ruconest.

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.

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 a supplemental BLA that seeks to extend the use of Opdivo (nivolumab) to patients with hepatocellular carcinoma after prior sorafenib therapy.