Topic: fda approval
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FDA Approves Wegovy Pill: New Weight Loss Tablet
The FDA has approved a daily oral pill version of the weight-loss drug Wegovy, offering a new, convenient alternative to the established weekly injection for managing obesity. Clinical trials showed the daily pill is highly effective, with participants achieving an average weight loss of 13.6% ov...
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Paradromics Wins FDA Approval for Human Brain Implant Trial
Paradromics has received FDA approval to begin human trials for its brain-computer interface, aimed at restoring communication for individuals with severe paralysis or speech impairments. The upcoming study will assess the long-term safety and effectiveness of the device in converting neural sign...
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Startups Innovating for a Better Life and Death
Entrepreneurs in heavily regulated fields like healthcare and deathcare cannot follow the "move fast and break things" model, as success requires navigating complex approvals, cultural sensitivities, and funding challenges. Founders such as Gabriel Sanchez (Enspectra Health) and Tom Harries (Eart...
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Google Maps COVID Vaccine Finder Disappears in Technical Glitch
A technical issue with Google Maps is preventing users from finding local COVID-19 vaccine providers, as searches return no results or distant locations. The problem affects both mobile and desktop versions, while searches for other vaccines like influenza continue to work normally. This outage c...
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Natural Cycles Birth Control App Ditches Thermometer for Wristband
Natural Cycles is launching a dedicated $130 wearable wristband that continuously monitors sleep data to power its fertility-tracking app, moving beyond its original basal body thermometer method. The company's proprietary band leverages existing FDA authorization for third-party wearables, allow...
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Revolutionary Blood Tests for Alzheimer's Are Now Available
The FDA has approved Roche's Elecsys pTau181 blood test, a revolutionary tool for early Alzheimer's screening that detects phosphorylated tau protein through a simple blood draw, reducing reliance on complex imaging or invasive procedures. These blood tests are particularly valuable alongside new...
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AI-Powered RADiCAIT Makes Medical Imaging Affordable at TechCrunch Disrupt 2025
RADiCAIT's AI platform converts standard CT scans into synthetic PET images, potentially replacing the need for complex and expensive PET procedures and expanding access to cancer diagnostics. The technology addresses challenges of PET scans, such as patient fasting, radioactive tracers, and geog...
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Crispr Pioneer Launches Startup for Custom Gene-Editing Therapies
Aurora Therapeutics, co-founded by CRISPR pioneer Jennifer Doudna, aims to scale personalized gene-editing treatments for rare diseases using a novel FDA regulatory pathway that allows approval based on data from a small number of patients. The company's initial focus is on phenylketonuria (PKU),...
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First Human Trial for Fentanyl Vaccine Begins
The first human trial for a fentanyl overdose vaccine has begun, aiming to proactively block the drug's effects before it reaches the brain. Fentanyl is a potent synthetic opioid, often unknowingly mixed into other drugs, and is the leading cause of overdose deaths in the U.S. Unlike reactionary ...
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AI Embryologist: The Future of Fertility Jobs
AI tool CHLOE, developed by Fairtility, is the first FDA-approved system for embryo assessment, using millions of data points to identify embryos with the highest implantation potential and improve pregnancy success rates. Traditional IVF faces challenges like costly and time-consuming genetic te...
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First Major Fentanyl Vaccine Trial Begins
A clinical trial is underway for a novel vaccine that trains the immune system to block fentanyl from reaching the brain, preventing its euphoric and deadly effects before they start. Fentanyl is extremely potent and often a hidden adulterant in street drugs, making accidental overdoses common, a...
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Therapists Secretly Use AI, AirPods Could Be Hearing Aids
A therapy client discovered his therapist was using AI to generate real-time advice during sessions without disclosure, raising ethical concerns about trust and confidentiality in mental health care. Apple AirPods Pro are now FDA-approved as hearing aids, offering an affordable and accessible alt...
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