Keyword: Zolgensma (onasemnogene abeparvovec)
The FDA hold on Novartis' Zolgensma IT will push the product's launch back by a year, SVB Leerink said, driving older patients to Biogen's Spinraza.
After early threats, the FDA finished reviewing the company's response to a citation for data manipulation and decided not to take any further action.
With 32 drugs remaining, FiercePharma’s March Madness-style quest to find the best drug names is advancing to to Round 3.
The Zolgensma data integrity crisis wiped out the "building trust with society" part of Vas Narasimahan's annual bonus in 2019.
Novartis hopes to remove a clinical hold on the high dose of an intrathecal form of Zolgensma but expects a filing based just on the lower doses.
Less than a year after buying a U.S. plant from AstraZeneca, Novartis’ biotech AveXis has it ready for production of its gene therapy Zolgensma.
Novartis plans to give away doses of its $2.1 million gene therapy Zolgensma, but critics are worried about its 'too crude' lottery approach.
Hamstrung by manufacturing issues, Novartis' CAR-T med Kymriah has lagged behind expectations. A new European facility could help its cause.
Roche's risdiplam, a potential 2020 entrant in spinal muscular atrophy, scored a FDA priority review on Monday.