Harbour Biomed has gained IND clearance from the FDA for HBM-7004, enabling the initiation of a first-in-human phase I trial in subjects with advanced solid tumors.
Arrivent Biopharma Inc. has obtained IND clearance from the FDA for ARR-002 (AV-P138-ADC), an antibody-drug conjugate (ADC) with an initial focus in ovarian and endometrial cancers and broader therapeutic potential across solid tumors. A phase I trial is expected to open in the second half of the year.
Reports that Sanofi SA has asked to withdraw its sBLA for Tzield (teplizumab) from the U.S. FDA’s Commissioner’s National Priority Voucher (CNPV) program is once again raising questions about whether leadership skepticism is overruling approval decisions at the agency.
Even before the U.S. FDA announced its one-day inspection pilot May 6, it already had test-flown 46 of the shorter inspections across several of its centers.
Three decades of trial-and-error, and the resulting safety data, in the oligonucleotide-based therapeutic space have paved way for the present-day innovations and the promise of “programmable,” precision medicine for patients, speakers at Bio Korea 2026 said April 28.
Regulatory uncertainty that dominated the life science sector in 2025 is transitioning into an execution framework for biotechnology companies, provided companies can tailor regulatory strategies early, and across the entire development cycle.
Regulatory uncertainty that dominated the life science sector in 2025 is transitioning into an execution framework for biotechnology companies, provided companies can tailor regulatory strategies early, and across the entire development cycle.
A month ahead of its June 5 PDUFA date, Arvinas Inc.’s vepdegestrant gained U.S. FDA approval for use in a specific type of advanced or metastatic breast cancer, becoming the first proteolysis targeting chimera, or PROTAC, drug to reach the market.
Axsome Therapeutics Inc. won U.S. FDA approval for Auvelity (AXS-05) to treat Alzheimer’s disease agitation, a condition that affects up to three-quarters of patients, gaining access to a $1 billion-plus market and a clean label that counters the boxed warning of a competitor. The agency accepted the supplemental NDA under priority review on Dec. 31, 2025, and the breakthrough therapy approval, specifically for agitation associated with dementia due to Alzheimer’s disease, came on the April 30, 2026, PDUFA date.
Following a discussion that focused more on a new personalized trial strategy rather than the proposed therapy, the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3-6 April 30 that Astrazeneca plc’s camizestrant demonstrated a clinically meaningful benefit in treating patients with HR+/HER2- metastatic breast cancer.
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