FDA
AstraZeneca’s Alexion on Monday secured the fourth indication for Ultomiris, which can now be used to treat the rare autoimmune condition neuromyelitis optica spectrum disorder.
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New FDA expert panels, such as recent meetings on SSRI use during pregnancy and on hormone replacement therapy during menopause, are drawing criticism for being one-sided. One leader says such panels are designed to reach a specific conclusion.
Amid an unprecedented turnover in leadership at the FDA and mass layoffs of staff, communication has crumbled and uncertainty runs rampant, leaving small and medium biopharma companies without a clear path forward for their therapies.
Aside from the rare disease market, Novo Nordisk also scored a key regulatory win last month for its blockbuster GLP-1 drug Wegovy, which can now be used to treat patients with metabolic dysfunction-associated steatohepatitis.
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The FDA granted accelerated approval Friday to Travere Therapeutics’ sparsentan, now to be marketed as Filspari, to reduce the burden of proteinuria in adults with primary IgA nephropathy.
The FDA’s Oncologic Drugs Advisory Committee voted 8-5 that two single-arm trials would be “sufficient to characterize the benefits and risks” of Jemperli in locally advanced rectal cancer.
The FDA placed 4D Molecular Therapeutics’ gene therapy program, 4D-310, on clinical hold, the company announced Thursday.
Wednesday, the FDA approved GSK’s daprodustat, now to be marketed as Jesduvroq, for the treatment of anemia due to chronic kidney disease in adult patients.
As the 118th Congress kicks into gear, biopharma industry observers speculate that 2023 may be a challenging year.
The FDA granted Eli Lilly’s Jaypirca accelerated approval for the treatment of adults with relapsed or refractory mantle cell lymphoma.
The FDA approved Merck’s Keytruda for the treatment of stage IB, II or IIIA non-small cell lung cancer after resection or platinum-based chemotherapy.
The FDA’s approval of Biogen and Eisai’s Leqembi and subsequent decision not to approve Eli Lilly’s donanemab have sparked debate anew about the anti-amyloid theory in Alzheimer’s.
The FDA granted Seagen’s tyrosine kinase inhibitor Tukysa accelerated approval for an aggressive form of colorectal cancer Thursday.
Thursday, Astellas announced that the FDA had lifted its clinical hold for the company’s experimental gene therapy trial for late-onset Pompe disease.