Health

EMA launches pilot program for ‘breakthrough’ medical devices in EU

EMA launched a pilot to give priority regulatory support to highly innovative Class III and IIb medical devices, testing a potential EU breakthrough pathway.

#medicaldevices, #ema, #healthpolicy, #innovation

FDA approves Otarmeni, first U.S.-cleared gene therapy for genetic hearing loss

FDA approves Otarmeni, the first U.S. gene therapy for OTOF-linked deafness; Regeneron's dual-AAV treatment wins accelerated approval, follow-up data required.

#fda, #regeneron, #genetherapy, #hearingloss, #otology

NHS England sets national maternal safety standards requiring early clot checks and faster treatment by 2027

NHS England requires all maternity services to use early VTE assessments and faster treatment, plus standards for epilepsy, mental health and hemorrhage by March 2027.

#maternity, #nhs, #maternalhealth, #vte

NHS England marks 20 years of bowel screening after almost 7 million screened in 2024/25

NHS England says almost 7 million people were screened for bowel cancer in 2024/25 as it marks 20 years and 70,000 cancers detected.

#bowelcancer, #nhs, #screening, #publichealth

H5N1 RNA detected in semen of California dairy bull, study finds

Researchers detected H5N1 genetic material in semen from a California dairy bull — the first such finding in cattle; no live virus was recovered and risks remain unclear.

#h5n1, #avianinfluenza, #dairy, #biosecurity

FDA Issues Draft Guidance on Using Next-Generation Sequencing to Assess Genome-Editing Safety

FDA's draft guidance explains how developers should use next-generation sequencing to detect off-target edits and chromosomal damage before human trials.

#geneediting, #fda, #ngs, #genetherapy

Brazil launches e‑SUS AF, national platform to manage medicines across SUS pharmacies

Brazil's Health Ministry launched e‑SUS AF, a national platform to modernize how medicines are bought, stocked and dispensed across the public SUS system.

#brazil, #health, #pharmacy, #healthit

Brazil's new cancer framework promises free advanced therapies through SUS and a push for domestic production

Brazil approved a framework to expand free access to advanced cancer therapies via SUS, speed regulatory reviews and favor domestic production.

#brazil, #healthcare, #cancer, #anvisa