Written: Katie Coffee
Photo: An infusion pump and IV bag in a hospital room. Annie Spratt / Unsplash
FDA grants accelerated approval to Rybrevant Faspro for head and neck cancer
The agency says it is the first drug approved in 10 years for patients previously treated with platinum chemotherapy.
The FDA cleared Janssen’s amivantamab and hyaluronidase-lpuj for adults with recurrent or metastatic head and neck squamous cell carcinoma that progressed on or after platinum chemotherapy and immunotherapy; it is not indicated for HPV-associated oropharyngeal disease [1]. In an open-label trial of 102 patients, 42% responded, and 56% of responders had responses lasting six months or longer, against roughly 20% or less for existing therapies [1]. Because the approval rests on response data, the FDA has required confirmatory studies [1].
Novartis confirms nine tumor reports in patients treated with Zolgensma
Two cases show the gene therapy’s vector integrated into patient DNA; the other seven have not been causally linked.
A Novartis spokesperson told BioSpace on Nov. 5 that nine tumors have been reported among more than 6,000 patients treated with the spinal muscular atrophy gene therapy [2]. In the two cases with evidence of vector integration, the patients were treated and remain under monitoring, the company said, adding that this potential risk is already in the prescribing information [2].
Wisconsin reports infant measles death, its first since 1990
The state has logged 431 cases in 13 counties this year.
The Wisconsin Department of Health Services said Nov. 5 that an infant died in connection with the ongoing outbreak in southwestern Wisconsin, with the coroner listing measles as the immediate cause [3]. As of Nov. 3 the state had reported 431 cases, its highest total in more than 35 years, and nine hospitalizations [3]. Officials urged residents to check their vaccination records [3].
Orlando clinic CEO and VA employee sentenced in $14 million kickback scheme
Prosecutors said a VA employee steered veterans to a holistic-care clinic in exchange for bribes.
Heriberto Rivera, 43, chief executive of Family Integrative Medicine of Orlando, received 13 months in prison, and Laurent Cassagnol, 43, a VA Community Care Program medical support assistant, received six months, the Justice Department said Nov. 5 [4]. According to court documents, Rivera paid Cassagnol to direct veterans to the clinic for acupuncture, chiropractic and other services, generating more than $14 million in fraudulent claims, of which over $11 million was paid [4]. The case began with a complaint to the VA inspector general’s fraud hotline [4].
Digest references
1. U.S. Food and Drug Administration. “FDA Grants Accelerated Approval to a New Treatment for Head and Neck Squamous Cell Carcinoma.” FDA news release, Nov. 5, 2026. fda.gov
2. McKenzie H. “Novartis confirms 9 reported cases of tumors in patients treated with Zolgensma.” BioSpace, Nov. 5, 2026. biospace.com
3. Wisconsin Department of Health Services. “DHS Reports a Death Connected to the Ongoing Measles Outbreak.” News release, Nov. 5, 2026. dhs.wisconsin.gov
4. U.S. Department of Justice. “CEO and VA Employee Sentenced for Paying and Receiving Illegal Health Care Kickbacks and Bribes.” Press release, Nov. 5, 2026. justice.gov
