FDA approves first plasmid DNA immunotherapy for recurrent respiratory papillomatosis
Inovio’s Voceryq wins accelerated approval for an HPV-driven airway disease that otherwise means repeat surgery.
The FDA on Oct. 30 granted accelerated approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), the first plasmid DNA-based immunotherapy approved in the U.S., for adults with recurrent respiratory papillomatosis [1]. Two plasmids, encoding HPV-6 and HPV-11 antigens and interleukin-12, are injected intramuscularly with the CELLECTRA 5PSP electroporation device [1], [2]. In an open-label trial of 32 adults, 7 of 26 patients (27%) with at least three surgeries in the prior year needed none in the next 12 months; Inovio must confirm benefit in post-approval trials [1], [2].
FDA early alert: Medline pulls all of its beds after two deaths and 16 serious injuries
The company is exiting the bed market entirely, citing fire and entrapment risks.
The FDA’s device center posted an early alert on Oct. 29 saying Medline is removing or correcting all Medline-brand homecare, bariatric and long-term care beds, plus pendants, accessories and parts [3]. As of Oct. 20, Medline had reported two deaths and 16 serious injuries tied to overheating components that can catch fire, and to entrapment or asphyxiation involving accessories, loose rails or a patient lying on a pendant [3]. The FDA advises keeping beds unplugged except while repositioning a patient and avoiding extension cords [3], [4].
Illinois man pleads guilty to $227 million Medicare COVID test kit fraud
Stolen beneficiary data bought from an overseas telemarketer powered the claims, prosecutors say.
Syed Murtuza Kablazada, 36, of Des Plaines, Illinois, pleaded guilty to two counts of health care fraud, the Justice Department said Oct. 30 [5]. Prosecutors said he and co-schemers acquired three Chicago-area labs in 2023, paid about $11 million to a purported Pakistan-based telemarketer for hundreds of thousands of beneficiaries’ personal data, and billed Medicare $227 million for COVID-19 test kits never requested or shipped; Medicare paid about $136 million [5]. He agreed to forfeit more than $46 million and faces up to 20 years in prison [5].
Stand-alone Medicare Part D premiums to jump 50% in 2027, KFF finds
Average monthly premiums rise from $34 to $51, unless enrollees shop before Dec. 7.
A KFF analysis reported Oct. 30 found average premiums for stand-alone Medicare drug plans will rise from $34 to $51 a month in 2027, with about 10.4 million enrollees paying more if they stay put and no zero-premium plans offered [6]. The average deductible climbs to $643 from $540; KFF ties part of the jump to CMS ending early a pilot that subsidized stand-alone plans in 2025 and 2026 [6]. CMS projects only a $1 average increase, which KFF says may assume enrollees switch plans, also the one remedy on offer through Dec. 7 [6].
Digest references
U.S. Food and Drug Administration, “FDA Approves First Plasmid DNA-based Immunotherapy for Adults with Recurrent Respiratory Papillomatosis,” FDA News Release, Oct. 30, 2026. fda.gov
Abigail Brooks, “Voceryq Gains FDA Accelerated Approval for Recurrent Respiratory Papillomatosis,” HCPLive, Oct. 30, 2026. hcplive.com
FDA Center for Devices and Radiological Health, “Early Alert: Medline Removes or Corrects All Medline Brand Beds and Accessories,” FDA, Oct. 29, 2026. fda.gov
Nick Paul Taylor, “FDA posts alert about Medline beds linked to 2 deaths,” MedTech Dive, Oct. 30, 2026. medtechdive.com
U.S. Department of Justice, Office of Public Affairs, “Indian National Pleads Guilty to $227M Medicare Fraud,” Oct. 30, 2026. justice.gov
Phil Galewitz, “Medicare Drug Plans Are Hiking Premiums While Trump Claims Victory on Medicine Prices,” KFF Health News, Oct. 30, 2026. kffhealthnews.org
Excerpt
FDA grants accelerated approval to Voceryq, the first plasmid DNA immunotherapy, for recurrent respiratory papillomatosis; Medline exits the bed market after an FDA early alert; and an Illinois man pleads guilty to $227M Medicare fraud.
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FDA approves first plasmid DNA immunotherapy for RRP
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FDA approves Voceryq, the first plasmid DNA immunotherapy, for recurrent respiratory papillomatosis. Plus Medline’s bed exit and a $227M fraud plea.
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