logo
Plus   Neg
Share
Email

Genentech: FDA Grants Priority Review For Rituxan In Pediatric Indication

Genentech, a member of the Roche Group (RHHBY), said the FDA has granted priority review for Rituxan (rituximab), in combination with glucocorticoids, for the treatment of granulomatosis with polyangiitis and microscopic polyangiitis in children above two years of age. Rituxan is currently approved for the treatment of four autoimmune indications.

The FDA accepted the company's sBLA which was based on data from the PePRS study, a Phase IIa, global study investigating intravenous Rituxan in 25 patients between six and 17 years of age.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Global PC shipments returned to growth in the second quarter of 2020 after seeing a significant decline in the preceding first quarter due to COVID-19 related supply-chain disruptions, according to reports by two research firms. The PC market returned to growth in the quarter as production ramped up and vendors restocked their supplies to near-normal levels. The bankruptcy filing of America's oldest apparel retailer Brooks Brothers has ignited significant interest from potential buyers for the brand. WHP Global and a venture backed by Authentic Brands Group LLC and Simon Property Group, Inc., are reportedly considering bids for the retailer. WHP Global owns the ANNE KLEIN and JOSEPH ABBOUD brands. Sundial Herbal Products has recalled around 65 products, which were misbranded and currently unapproved drugs, the U.S. Food and Drug Administration said in a statement. The recall follows an order by a federal judge in June to stop distributing the company's unapproved new drugs. The affected items include herbal products and dietary supplements.
Follow RTT