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First-ever gene therapy for hearing loss gets FDA approval: ‘Groundbreaking’
A new therapy for genetic hearing loss has just been approved by the Food and Drug Administration (FDA).
The treatment, Otarmeni (lunsotogene parvec-cwha), is the first-ever dual adeno-associated virus (AAV) vector-based gene therapy — meaning it uses two harmless viruses to deliver the therapy into cells.
In an FDA news release, the agency called the therapy “groundbreaking,” noting its potential to treat both pediatric and adult patients with “severe to profound” hearing loss linked to the OTOF gene.
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Positive results from drug trials were published in The New England Journal of Medicine in 2025, confirming that the gene therapy “improved hearing in patients with OTOF-related deafness, enabling natural acoustic hearing and normalizing hearing sensitivity in three of 12 treated patients.”
The FDA approval marks the first disease-modifying treatment for OTOF-related deafness.
This is the sixth drug approval under the FDA commissioner’s National Priority Voucher (CNPV) pilot program — and the first gene therapy to be approved through the initiative, according to the announcement.
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“Today’s approval is a significant milestone in the treatment of genetic hearing loss,” FDA Commissioner Marty Makary, MD, commented in a statement.
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“Through the national priority voucher pilot program, the agency is accelerating therapies for rare diseases with unmet medical needs while proving we can successfully review even the most complex submissions – such as novel dual-vector gene therapies and combination products requiring coordination across multiple offices and centers – in significantly shortened timeframes.”
Otarmeni is administered surgically as a one-time treatment, using a needle and a tiny tube to deliver the medicine directly into the inner ear (the cochlea) in both ears.
The therapy works by delivering a healthy copy of the OTOF gene to key cells in the inner ear, helping to restore the protein otoferlin so that auditory signals can be sent to the brain, according to the FDA.
The treatment is intended for patients with preserved outer hair cell function and for those with no prior cochlear implant in the same ear. Side effects may include middle ear infection, nausea, dizziness and procedural pain.
The FDA will host a public meeting on June 4 to discuss program implementation, eligibility criteria and other processes for distribution, according to the announcement.
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Barricaded person in custody after two USF doctoral students vanish from Tampa campus and nearby home
One person is in custody in connection to two missing University of South Florida doctoral students, authorities said Friday.
The Hillsborough County Sheriff’s Office said it closed down a Tampa neighborhood Friday afternoon and took into custody a barricaded person linked to the disappearance of Zamil Limon and Nahida Bristy, both 27, who were last seen separately on April 16.
The sheriff’s office announced at about 11:15 a.m. Friday that it had closed the entrance and exit of the Lake Forest Community “due to a police investigation related to the missing USF students.”
“The situation has been resolved. One individual is in custody,” they said.
Limon, a USF doctoral student pursuing a degree in geography and environmental science and policy, was last seen at his home around 9 a.m. on April 16.
Bristy, a USF doctoral student studying chemical engineering, was last seen around 10 that morning on the USF Tampa campus at the NES Building.
A family friend notified police April 17 at approximately 4:50 p.m. after concern grew over being unable to contact Limon and Bristy.
Both have since been added to the state and national missing persons databases, police said.
The sheriff’s office said that they will have a news conference Friday to announce additional details.
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Homeowner confronts CNN reporter during live wildfire report, orders crew off property
A live report from CNN in Georgia was interrupted Friday when a homeowner confronted reporter Derek Van Dam while he was covering wildfire damage in Brantley County, forcing the crew to leave the property as fires continued to spread across the region.
The confrontation unfolded mid-broadcast as the woman shouted at the crew to leave, cutting off the report and shifting the focus from wildfire destruction to a tense exchange on private property.
“I don’t want nobody near my house! My dogs are out there. Get away, get away!” the homeowner yelled.
The incident occurred as Van Dam was reporting on fast-moving wildfires fueled by drought conditions and shifting winds, with local officials issuing mandatory evacuations and curfews in affected areas.
The fires have already scorched tens of thousands of acres and destroyed dozens of homes, underscoring the volatility on the ground as residents remain on edge.
Van Dam acknowledged the homeowner’s demands and quickly de-escalated the situation while exiting the scene.
“You got it, you got it. We are … OK. Yeah, we’re going to leave it here. OK? You got it,” Van Dam said.
Back in the studio, co-anchor Pamela Brown reacted to the abrupt end of the segment as the live shot cut away from the field.
“Let’s hope Derek gets to safety there,” Brown said.
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Earlier in the report, Van Dam described rapidly changing conditions that complicated both reporting and firefighting efforts, noting how wind shifts altered air quality within minutes.
“As we were setting up for this live shot, the winds shifted and changed. We put on a mask because there’s this absolutely putrid chemical burning type smell from something that is smoldering in the distance over my left shoulder,” Van Dam said.
He explained that the sudden change in air conditions posed immediate physical effects on the crew, highlighting the unpredictable nature of the fire environment.
“We didn’t have that smell just moments ago,” Van Dam said. “But the wind shifts brought that back into it, and it started to make us feel a little bit nauseous, and lightheaded, so we put on the mask for that particular reason.”
“But I think it really illustrates the point that the shifting winds are what’s making this firefighting effort so challenging on the ground for the firefighters.”
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The report also documented the scale of destruction left behind, including burned vehicles and extreme heat damage consistent with intense wildfire conditions.
“Look at these scorched vehicles. Again, we’re in Brantley County. This is southeastern Georgia, on the scarred area from the Highway 82 fire,” Van Dam said.
“The windshield, the back windshield of this vehicle? Yeah, that glass melted. You need temperatures over 2,500°F in order to melt glass. So, that just gives you an idea of how hot it was.”
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Footage shows masked teen allegedly body-slamming girl onto NYC sidewalk after she refused phone number
A 14-year-old boy has been charged with assault after video shows him allegedly body-slamming a teen girl onto a New York City sidewalk and stomping on her head.
The incident began after the girl refused to give her attacker her phone number, the New York Post reported, citing unidentified sources.
Footage of the violent encounter shows a masked 14-year-old confronting a 15-year-old girl on an East Harlem street in Upper Manhattan around 3:30 p.m. Monday, shortly after school let out.
While blocking her path in a crosswalk, the unnamed teen suspect threatens to “knock the s— outta” the girl.
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“Do it,” someone is heard saying off-camera, egging on the suspect.
“Nah, nah, you stand right here,” the teen says as the girl tries walking around him.
“Get the f— away from me,” she responds as he pushes her back, according to the video.
The girl then walks around a parked car in an attempt to get away from the aggressive teen. As she makes her onto the sidewalk, the masked teen is seen grabbing her from behind and lifting her into the air before slamming her onto the pavement.
The teen then stomped on her head as she lied on the ground in pain, before walking away.
The New York Police Department said officers responded to a 911 call for an assault in progress Monday and upon arrival, were informed that a 15-year-old had been assaulted by an unidentified individual.
“The individual threw the victim to the ground and kicked her in the head, causing minor injuries. EMS responded and transported the victim to NYC Health+Hospitals/Harlem in stable condition,” police told Fox News Digital.
The suspect, a 14-year-old boy, was arrested Wednesday and charged with assault, police said.
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“This is not even bullying, this is outright assault — and he could have killed her,” the victim’s mother Lucinda Arroyo said, according to the Post. “She was very angry at why he escalated so quickly from one thing to another. And you can tell [in the video] she just wanted to walk away from him because he’s bad news. She’s known him as someone who’s bad news for a while.”
The attack caused a concussion, bleeding, a possible brain injury, splitting headaches, and a twisted neck, injuries that will necessitate ongoing physical therapy, the mother said, according to the outlet.
“The video was passed around like entertainment, and that pissed me off the most. She’s ignoring him, so he basically forced her to pay attention to him. And his friends are laughing after that. It’s not just one bully, but community bullying,” the mother noted, according to the outlet.
“She’s not going back to that school… that school can’t keep her safe,” she said.
But the suspect’s mom, Selma Allen, described her son as a “humble” Christian and claimed that the girl had bullied him at school, the outlet reported.
“She was being a bully to him, that’s it,” she told the outlet. “He’s been complaining about her. I bring it to the principal’s attention, but he don’t address it. The way my son is being bullied, he doesn’t want to go to school.”
The suspect’s mother denied that her son was attempting to obtain the girl’s number, saying that they were friends who regularly exchanged messages on Instagram and WhatsApp, the Post reported.
“It’s retaliation because she pushed him first,” Allen said, failing to supply video she claimed she had of the girl shoving the boy, the outlet noted. “He don’t provoke nobody. But if you provoke him, he will lash out.”
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