Science & Tech

MHRA warns parents to stop using infant rectal 'gas' catheters and dispose of unused devices

MHRA warns parents and clinicians to stop using infant rectal catheters marketed for colic or gas and to dispose of unused devices, citing unknown risks.

#health, #mhra, #infants, #medicaldevices, #colic

UK regulator issues safety alert for some ResMed Astral ventilators after risk of sudden stoppage

UK regulator warns ResMed Astral 100/150 ventilators made before Oct 2024 can stop delivering therapy due to leaking supercapacitors; patients must not stop use.

#health, #safety, #medical-devices, #resmed

MHRA details pilot to cut Phase 1 clinical trial review to 14 days by end of 2026

MHRA outlines a staged pilot to reduce first-assessment times for eligible Phase 1 trials in healthy volunteers to 14 days by end-2026, with tight eligibility and limited slots.

#mhra, #clinicaltrials, #uk, #phase1

FDA approves Moderna’s first seasonal mRNA flu vaccine — full approval for 50–64, accelerated OK for 65+

FDA approved Moderna’s mRNA-1010 seasonal flu vaccine (mFLUSIVA), giving full approval for ages 50–64 and accelerated approval for 65+, pending a confirmatory study.

$MRNA, #moderna, #influenza, #fda, #vaccines

Once‑Weekly Oral HIV Pill Maintains Viral Suppression Through 48 Weeks in Phase 3 Trial

Phase 3 Lancet study: a once‑weekly islatravir‑lenacapavir single‑tablet regimen maintained HIV‑1 viral suppression through 48 weeks, matching daily therapy.

#hiv, #islatravir, #lenacapavir, #antiretroviral, #clinicaltrial

Trump Directs HHS to Pursue 'Gold Standard' Childhood Vaccine Guidance, Urging Separate MMR Shots

On Aug. 10, Trump signed an order directing HHS to pursue 'Gold Standard' childhood vaccine guidance, urging separate MMR shots — but courts and availability limit immediate change.

#vaccines, #publichealth, #trump, #hhs

Radioligand 177Lu-PSMA-617 Delays Radiographic Progression in PSMA-Positive Hormone-Sensitive Metastatic Prostate Cancer, Phase 3 Trial Shows

Phase 3 PSMAddition trial found 177Lu‑PSMA‑617 added to hormonal therapy reduced risk of radiographic progression in PSMA‑positive mHSPC.

#prostatecancer, #radioligandtherapy, #pluvicto, #clinicaltrials

FDA Grants Accelerated Approval to Replimune’s Tudriqev for PD-1–Resistant Advanced Melanoma

FDA gives accelerated approval to Replimune’s Tudriqev with nivolumab for adults with PD‑1–resistant unresectable advanced melanoma; confirmatory trials required.

$RPLM, #melanoma, #fda, #oncology, #replimune, #drugapproval

UK regulator warns hospitals to check Dräger Atlan anaesthesia workstations after expanded safety action

Britain's MHRA on Aug. 4 told hospitals to check Dräger Atlan anaesthesia workstations after an expanded safety action over a ventilator motor defect.

#medicaldevices, #patient-safety, #drager, #mhra

Pfizer says Phase 3 LITFULO trials met key vitiligo endpoints; plans global regulatory filings

Pfizer said Phase 3 trials of LITFULO (ritlecitinib) met key endpoints in nonsegmental vitiligo across 2,174 patients, and it plans global regulatory filings.

$PFE, #pfizer, #vitiligo, #ritlecitinib

EU Authorizes Pfizer-BioNTech XFG-Adapted COVID-19 Vaccine for Ages 6 Months and Up

EU clears Pfizer and BioNTech’s 2026–27 XFG-adapted COVID-19 vaccine for people 6 months and older ahead of the 2026–27 respiratory season.

#covid19, #vaccine, #pfizer, #biontech, #xfg

Deramiocel improves arm function and cardiac measures in phase 3 trial as FDA advisory panel reviews Capricor's application

Phase 3 trial of deramiocel (CAP-1002) showed significant benefits on upper-limb function and cardiac measures; FDA advisory panel is reviewing the data.

$CAPR, #duchenne, #muscular-dystrophy, #biotech, #fda

19-Protein Blood Panel Estimates When People with ALS-Linked Genes May Become Symptomatic

An NIH-backed study found a 19-protein blood panel predicts when carriers of ALS-linked variants may develop symptoms, with about an 18-month average error.

#health, #als, #biomarkers, #neurology

FDA Approves Lipfendra, Merck’s First Oral PCSK9 Inhibitor, to Lower LDL in Adults

FDA approves Merck's Lipfendra (enlicitide), the first oral PCSK9 inhibitor, for adults with hypercholesterolemia as a once-daily LDL-lowering pill.

$MRK, #merck, #lipfendra, #pcsk9, #cholesterol

WHO updates dementia guidance, says up to 45% of risk linked to modifiable factors

WHO's new guidelines recommend exercise, social engagement, hearing aids and less air pollution — and advise against routine vitamins or supplements to lower dementia risk.

#dementia, #who, #publichealth, #cognitivehealth