FDA
The FDA in a complete response letter to Replimune maintained its original objection to the single-arm trial the biotech used to support the application for RP1.
FEATURED STORIES
The FDA has some big verdicts lined up in the second quarter, including one for a closely watched obesity drug that many anticipate will further intensify competition in weight loss.
Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of new approach methodologies, experts told BioSpace, particularly emphasizing the agency’s recommendations around defining NAMs’ regulatory purpose.
The FDA’s Commissioner’s National Priority Voucher program, unveiled in June 2025, is “shrouded in secrecy,” Democratic representative Jake Auchincloss said last month, as regulatory and biopharma leaders try to decode the criteria for investigational or approved drugs to receive a voucher.
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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.
Johnson & Johnson discontinued the Phase III trial of an investigational HIV vaccine regimen Wednesday after an independent review showed it was ineffective at preventing disease.
Servier and Taiho Oncology announced Tuesday that Lonsurf in combination with bevacizumab improved overall survival rates in patients with refractory metastatic colorectal cancer.