South Korea’s GC Biopharma Corp. has gained U.S. FDA approval for its immune-deficiency plasma drug, Alyglo (immune globulin intravenous, human-stwk; IVIG-SN 10%), five months after refiling its BLA and before its PDUFA date of Jan. 13, 2024.
Avstera Therapeutics Corp. has received FDA clearance of its IND application for HDAC6 inhibitor AVS-100. Avstera intends to initiate a phase Ia/b trial in the first half of 2024 to evaluate AVS-100 alone and in combination with pembrolizumab in locally advanced or metastatic solid tumors.
Nrx Pharmaceuticals Inc. has announced FDA clearance of its IND application for the use of NRX-101 (lurasidone hydrochloride/D-cycloserine) for the treatment of complicated urinary tract infections (cUTI).
Shares of Checkpoint Therapeutics Inc. dropped 44.8% Dec. 18 on news that the U.S. FDA issued a complete response letter (CRL), delaying potential approval of PD-L1 antibody cosibelimab in metastatic or locally advanced cutaneous squamous cell carcinoma. The FDA had accepted in March the BLA, seeking use for treating patients who are not candidates for curative surgery or radiation, setting a Jan. 3, 2024, PDUFA date.
Neuroone Medical Technologies Corp. received U.S. FDA 510(k) clearance for its Onerf ablation system which is capable of both recording electrical activity and ablation of nervous tissue.
Neuexcell Therapeutics Inc. has announced that NXL-004, an investigational AAV gene therapy product being developed for the treatment of malignant glioma, has been awarded orphan drug designation by the FDA.
Following the recommendation of its Oncology Drugs Advisory Committee, the U.S. FDA approved U.S. Worldmeds LLC’s eflornithine 192-mg tablets for use as a maintenance therapy in patients with high-risk neuroblastoma. Branded Iwilfin, the specific, irreversible inhibitor of ornithine decarboxylase previously known as DFMO, is expected to be available in the coming weeks.
The FDA’s ongoing efforts to modernize the 510(k) program produced three draft guidances in the waning days of fiscal year 2023, one of which is a draft for the scenarios in which clinical data would be required for a 510(k) application.
Artificial intelligence has morphed from a buzzword referencing a popular curiosity to a series of national security and competitiveness considerations, which was reflected in the tone of a recent hearing in the U.S. House of Representatives.
The U.S. FDA’s draft guidance for selection of a predicate device in 510(k) submissions is part of a larger effort to overhaul the 510(k) program, but industry’s response is that this draft guidance goes too far.
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