Regulatory
Friday’s approval comes after a previous rejection in October 2023 due to manufacturing concerns.
The result comes months after an FDA advisory committee flagged the risk of potential overtreatment with perioperative regimens.
The FDA has six target action dates ahead to round out September as drugs for gastroparesis, Niemann-Pick disease type C and more await decisions.
Tecentriq Hybreza, which combines Roche’s Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology, is being touted as the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy.
One patient developed elevated liver blood tests after receiving Astellas Pharma’s non-hormonal small molecule blocker, leading the regulator to add a warning to the drug’s label.
With a Friday advisory committee meeting looming, the sole indication for Intercept Pharmaceuticals’ Ocaliva appears to be at risk as the regulator flags issues regarding its post-marketing results.
In this episode, Lori and guests discuss practical approaches regarding artificial intelligence and investor and industry confidence in its current state.
Join our webinar to explore strategies, best practices, and the evolving landscape of QARA in today’s dynamic market.
As Congress considers a bill that aims to distance U.S. biopharma from five Chinese companies, the industry must emphasize the importance of prioritizing patient care over power plays.
With the regulator’s traditional green light in IgA nephropathy, Filspari is up against Novartis’ Fabhalta—which won accelerated approval last month—and Calliditas’ Tarpeyo, which was approved in December 2023.
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