Regulatory
With the FDA’s approval, Fasenra will compete with GSK’s Nucala, which in December 2017 became the first biologic approved for eosinophilic granulomatosis with polyangiitis.
The mesothelioma approval for the Keytruda combination regimen potentially unlocks a $12 billion market opportunity, according to a recent report from research firm IMARC Group.
The FDA’s approval of Kisqali in combination with an aromatase inhibitor allows Novartis to target patients with earlier breast cancer who are at risk of recurrence.
Boehringer Ingelheim’s investigational compound nerandomilast, which targets the PDE4B enzyme involved in fibrosis and inflammation in the lungs, met its primary endpoint in a late-stage study.
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.
PRESS RELEASES