FDA’s approval Friday of Lupkynis voclosporin will allow Aurinia to introduce an oral therapy into a new marketplace for drugs to treat lupus nephritis, for which there had been no approved treatments before last month’s...

No benefit in Phase III for Incyte, Novartis JAK inhibitorJakafi ruxolitinib from Incyte Corp. (NASDAQ:INCY) and Novartis AG (NYSE:NVS; SIX:NOVN) plus standard of care vs. SOC alone did not reduce the proportion of patients with severe complications...

NIH panel says bamlanivimab should not be considered standard-of-care for COVID-19NIH’s COVID-19 Treatment Guidelines Panel said there is not enough data to recommend either for or against use of bamlanivimab from Eli Lilly and Co. (NYSE:LLY)...

bluebird delays sickle cell BLAbluebird bio Inc. (NASDAQ:BLUE) lost $9.72 (17%) to $48.83 Thursday after disclosing its BLA submission to FDA for LentiGlobin to treat sickle cell disease will be delayed to late 2022 from 2H21....

Data from NIH’s master protocol trial was the cornerstone for the first FDA approval of a COVID-19 therapy, granted to Gilead’s Veklury Thursday. The approval highlights the critical role of master protocols for generating substantive evidence...

Having turned photosynthetic bacteria into protein production machines, Lumen believes it has cracked the code to making cheap, oral biologics for widespread diseases in the Western and developing worlds....

The European Commission is nearing a procurement deal for CureVac’s COVID-19 mRNA-based vaccine, which would add mechanistic diversity of the portfolio of vaccines it is pursuing. The EU has secured doses of an adenovirus vector...

While most master protocols for COVID-19 have converged on an overlapping set of experimental therapies, the COVID R&D Alliance’s adaptive trial is kicking off with five therapeutic targets largely untouched in the indication. Three members...

A Phase III miss for a second IL-6 inhibitor in COVID-19 patients could be the death knell for the drug class in the disease. But the mortality benefit demonstrated by dexamethasone suggests a broader immunosuppressive...

As real-world data continue to take on a more prominent role in clinical development, Gilead’s comparison of severe COVID-19 patients in a clinical trial of remdesivir versus a real-world cohort raises questions of how and...