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.
Tag Archive for: FDA
Friday’s approval comes after a previous rejection in October 2023 due to manufacturing concerns.
The expanded capacity will help the drugmakers meet the demand for Beyfortus ahead of the RSV season. The therapy was in tight supply last year.
Yesterday the FDA issued an alert about Astellas’ Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, stating that it can cause rare but serious liver injury. The agency stated that if there are signs and symptoms suggesting liver injury, halting use of the medicine could prevent worsening liver injury and potentially return liver function to normal.
With today’s 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.
The reviewers, in briefing documents published on the FDA’s website, said the confirmatory trial for the drug did not provide evidence that it was effective in patients with primary biliary cholangitis (PBC).
The treatment, ersodetug, is currently being tested on participants with congenital hyperinsulinism, a genetic disorder that causes low blood sugar.
Amy Emerson is stepping down on the heels of the FDA last month rejecting Lykos Therapeutics’ MDMA-based therapy for post-traumatic stress disorder and the company laying off three-quarters of its staff.
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.
The FDA clearance, announced late on Thursday by the company, makes the vaccine, called ACAM2000, the second approved shot against mpox in the United States after Bavarian Nordic’s (BAVA.CO) Jynneos.