BioCentury | Jan 24, 2021
Regulation

Lupus nephritis patients gain oral option as FDA approves Aurinia’s Lupkynis

...well as its route of administration.Aurinia’s drug will also enter a marketplace in which Benlysta belimumab...
BioCentury | Dec 19, 2020
Product Development

Dec. 18 Quick Takes: FDA approves expanded label for Benlysta and first oral prostate cancer therapy; plus Novartis, FibroGen, A2i, China’s NRDL and more

...By BioCentury Staff FDA expands Benlysta label to include lupus nephritisFDA approved Benlysta belimumab from GlaxoSmithKline...
...Programmed cell death 1 PD-L1 (B7-H1; CD274) – Programmed cell death 1 ligand 1 BC Staff Benlysta, belimumab...
BioCentury | Nov 7, 2020
Product Development

Amgen’s adaptive solution to lupus

...patient recruitment have slowed progress in lupus. Benlysta belimumab...
BioCentury | Jun 4, 2020
Product Development

With impending Benlysta submission, GSK seeking new paradigm in lupus nephritis treatment

...that although lupus nephritis is a complication of systemic lupus erythematosis (SLE), for which Benlysta belimumab...
...looking for an absolute benefit of 10%. On BLISS-LN’s primary endpoint, significantly more patients receiving belimumab...
...the treatment landscape (see “Three Late-Stage Wins” ). Targets BLyS (BAFF; TNFSF13B) Paul Bonanos, Associate Editor Benlysta, belimumab...
BioCentury | Dec 18, 2019
Company News

Dec. 18 Company Quick Takes: FDA approves enfortumab vedotin; plus ODAC roundup, Illumina-PacBio, Benlysta, Ultragenyx, Syros-GBT, Xtandi

...plc (LSE:GSK; NYSE:GSK) is on track for regulatory submissions in 1H20 seeking to expand Benlysta belimumab’s...
BioCentury | Nov 13, 2019
Clinical News

Three late-stage wins shift the clinical landscape in SLE

...and TNFSF13 to impact development and survival of plasma cells and mature B cells. Benlysta belimumab...
BioCentury | Sep 20, 2019
Company News

Xospata poised for EU approval under accelerated assessment

...first-line advanced renal cell carcinoma in combination with Inlyta axitinib from Pfizer Inc. (NYSE:PFE); Benlysta belimumab...
BioCentury | Aug 29, 2019
Clinical News

New lupus endpoint key to Phase III success for AZ’s anifrolumab

...the second new medicine for lupus in over 60 years. In 2011, FDA approved Benlysta belimumab...
BioCentury | Jul 19, 2019
Company News

July 19 Company Quick Takes: First biosimilars of Avastin, Herceptin launched; plus Gilenya, Celltrion-Nan Fung and Celgene

...plaque psoriasis. Benlysta approved in China for lupus NMPA approved the IV formulation of Benlysta belimumab...
BioCentury | Apr 29, 2019
Company News

April 29 Quick Takes: Takeda, Emendo, ViiV, Zynquista, Benlysta and more

...I diabetes. Benlysta first approved drug in U.S. for children with lupus FDA approved Benlysta belimumab...
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