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FDA approved Replimune's melanoma treatment after rejecting it twice

The agency had twice rejected the engineered viral therapy over concerns about the design of Replimune's clinical trial [...]

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Destination
Trump administration adds note rejecting 'gender ideology' to government websites

Newly restored pages on the websites of government agencies like the Food and Drug Administration (FDA) and Substance Abuse and Mental Health Services Administration (SAMHSA) now include a disclaimer [...]

Match Score: 104.79

qz
FDA advisory panel backed Replimune's twice-rejected melanoma treatment in 10-3 vote

The vote raises the chance the FDA will approve RP1, an engineered viral immunotherapy, ahead of an Aug. 2 decision deadline [...]

Match Score: 84.68

qz
Replimune is resubmitting its twice-rejected melanoma drug after FDA leadership exodus

The FDA rejected vusolimogene oderparepvec twice under former Commissioner Marty Makary, who stepped down earlier this month [...]

Match Score: 83.95

Destination
The FDA rolls out its own AI to speed up clinical reviews and scientific evaluations

The FDA has launched the generative AI tool, Elsa, agency-wide to help its employees with everything from clinical reviews to investigations. Sure, we're living in a time of widespread disinforma [...]

Match Score: 66.16

Destination
FDA employees say the agency's Elsa generative AI hallucinates entire studies

Current and former members of the FDA told CNN about issues with the Elsa generative AI tool unveiled by the federal agency last month. Three employees said that in practice, Elsa has hallucinated non [...]

Match Score: 47.26

Destination
Apple Watch Series 11 receives FDA clearance for hypertension alerts

Apple's Awe Dropping event started with dramatic health testimonials from Apple Watch users, then revealed a key new feature for the new Watch Series 11: hypertension alerts. The function had yet [...]

Match Score: 46.21

thenextweb
mbiomics raises €30M Series A to take its microbiome cancer co-therapy into clinical trials

The Munich techbio company is developing a live bacterial product designed to enhance immune checkpoint inhibitor response in advanced melanoma, with a Phase 1B study planned for 2027 mbiomics GmbH, a [...]

Match Score: 44.29

Destination
The FDA approves human trials for pig kidney transplants

Despite how it sounds, a xenotransplant isn't something from the latest Alien movie. It's an increasingly credible science: the transplantation of animal organs into humans. The field took o [...]

Match Score: 43.41

Destination
The FDA and EU clear Nuance Audio, smart glasses with built-in hearing aids, for sale

Nuance Audio, new "hearing glasses" from EssilorLuxottica, have received FDA clearance and "a CE marking under the Medical Devices regulation in the EU," making them officially rea [...]

Match Score: 42.53