The recent emphasis on eliminating animal studies for preclinical studies of U.S. FDA-regulated products amplifies a long-standing concern, but the U.S. Government Accountability Office raised the question of whether organ-on-a-chip methods are ready to fill the gap.
Hinge Health Inc.’s flexibility produced big rewards as the digital therapy company for physical rehabilitation finally began trading on the NYSE under the symbol HNGE on May 22 after delaying its IPO twice. Hinge co-founders Daniel Perez and Gabriel Mecklenburg rang the opening bell for the stock exchange to celebrate the offering’s $437 million haul.
U.S. FDA commissioner Marty Makary appeared at the May 22 Senate Appropriations Committee with the news the White House proposed an FDA budget for fiscal 2026 of $6.8 billion including user fees. This is a cut of 11.5% that will not likely go over well on Capitol Hill as the FY 2026 budget process unwinds.
The recent 8-1 adcom vote against the U.S. applicability of Genentech Inc.’s Starglo trial is being seen as a warning signal expanding beyond the confirmatory trial for Columvi (glofitamab) as a treatment for relapsed/refractory diffuse large B-cell lymphoma.
More telling than the U.S. FDA’s Oncologic Drugs Advisory Committee’s 4-5 vote May 21 on the overall benefit-risk of Urogen Pharma Inc.’s UGN-102 (mitomycin) is that the panel’s urology specialists and the patient representative all voted yes, saying the drug would be an important alternative to what is often a continuing cycle of surgery for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
Medtronic plc revealed plans to spin off its underperforming diabetes unit as a separate public company during its fourth quarter 2025 earnings call May 21. The company expects to complete the separation within 18 months.
The recent emphasis on eliminating animal studies for preclinical studies of U.S. FDA-regulated products amplifies a long-standing concern, but the U.S. Government Accountability Office raised the question of whether organ-on-a-chip methods are ready to fill the gap.
A drug that failed in a phase III trial in 2019 is being brought back to the clinic by Repronovo SA, a fertility and women’s health startup that has raised $65 million in a series A. The money will fund a phase II study of nolasiban in improving success rates in assisted reproductive technology, the same indication as the previous phase III failure.
Medtronic plc revealed plans to spin off its underperforming diabetes unit as a separate public company during its fourth quarter 2025 earnings call on May 21. The company expects to complete the separation within 18 months.
Fujirebio Diagnostics Inc.’s Alzheimer’s disease assay received the U.S. FDA’s first clearance for a blood test for the debilitating neurodegenerative disease. Fujirebio’s Lumipulse G pTau217/ß-Amyloid 1-42 plasma ratio is indicated for the early detection of amyloid plaques associated with Alzheimer’s disease in symptomatic individuals aged 55 years and older.
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