Five years after the COVID-19 pandemic gripped the world, the U.S. FDA is moving away from annual routine boosters for all children and adults. Instead of that one-size-fits-all regulatory framework by which it has granted broad COVID-19 vaccine marketing authorization for all Americans older than 6 months, the agency said it’s adopting a policy akin to that followed in Europe, which now restricts the vaccines to older adults and those at high risk for severe disease.
The U.S. Department of Health and Human Services (HHS) put biopharma companies on notice May 20: It’s time to commit to reducing prescription drug prices to reflect most-favored-nation (MFN) pricing in accordance with President Donald Trump’s May 12 executive order. HHS said it expects manufacturers to commit to aligning their U.S. prices for all brand products across all markets that don’t currently have generic or biosimilar competition with the lowest price of a set of economic peer countries.
Suzhou Sanegene Bio Inc. has gained clinical trial approval in China for SGB-3383 for the treatment of complement-mediated kidney diseases, including IgA nephropathy, C3 glomerulopathy, immune complex-mediated membranoproliferative glomerulonephritis and atypical hemolytic uremic syndrome.
Repair Biotechnologies Inc.’s REP-0003 has been awarded orphan drug designation by the FDA for the treatment of homozygous familial hypercholesterolemia (HoFH).
The U.S. FDA’s decision to phase out animal testing for INDs is driving a new market of alternative, nonanimal testing technologies like organoids and organs-on-a-chip, speakers at Bio Korea 2025 said.
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.
With a PDUFA date less than four weeks away, Urogen Pharma Inc. has been having a rough ride on the Street since the U.S. FDA released a joint briefing document for the May 21 Oncologic Drugs Advisory Committee meeting on UGN-102 (mitomycin).
Frets about how the new federal administration might affect prospects for vaccines were quelled at least somewhat by the U.S. FDA green light for Novavax Inc.’s COVID-19 vaccine Nuvaxovid, indicated for adults 65 and over and people 12-64 years old with at least one underlying condition that puts them at risk of severe outcomes from infection by the virus.
The U.S. FDA approved 20 drugs for market in April, slightly down from 22 in March, 16 in February and 12 in January. This brings the total number of FDA approvals for the first four months of 2025 to 70, a decrease from 77 in the same period last year but higher than the 50 drugs approved during the first four months of 2023 and 48 in 2022. Despite the decrease from last year, the 2025 total remains the second-highest in BioWorld’s records for this time frame.
Incyte Corp.’s Zynyz (retifanlimab-dlwr) has received another U.S. FDA approval and put some distance between it and a 2021 complete response letter. The FDA gave the humanized monoclonal antibody targeting PD-1 the nod for first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal. That makes it the only approved first-line treatment for this cancer.
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