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First-ever gene therapy for hearing loss gets FDA approval: ‘Groundbreaking’

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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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Texas substitute teacher accused of improper relationship with student, alarming parents

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A former substitute teacher in Texas was arrested and charged with an “improper relationship” with a student, authorities said.

According to a Facebook post from the Llano County Sheriff’s Department, Angela Palmares, 27, was arrested after the Llano Independent School District notified authorities Tuesday of an alleged relationship between her and a student

The sheriff’s office did not immediately respond to Fox News Digital’s request for comment.

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Palmares is being held on $150,000 bond, according to jail records.

The Llano Independent School District notified authorities of the alleged relationship, prompting the investigation.

Following the report, the teacher, who last worked for the district April 2, was removed from the district’s list of available substitutes.

According to a letter sent to families from Llano Independent School District Superintendent Mac Edwards, the former substitute engaged in “inappropriate communication with students, specifically through a social media platform outside of the school day.”

Edwards said in his letter to families that the district has been in contact with families of students who may have been affected.

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“The district takes all allegations of this nature extremely seriously and remains committed to providing a safe and supportive environment to students,” he said. “At this time, we are unable to provide additional details due to personnel and student privacy considerations.”

Further details were not provided by the school district or the sheriff’s office.

The Llano County Sheriff’s Office Criminal Investigation Division began investigating the allegations Wednesday, and after conducting interviews and reviewing evidence, the investigation led to an arrest warrant.

The Criminal Investigation Division, in collaboration with the Texas Department of Public Safety Fusion Center, located Palmares in Bell County.

“Palmares has been charged with Improper Relationship between an Educator and a Student, a 2nd Degree Felony,” a Facebook post said.

The investigation remains ongoing, and the sheriff’s office asks anyone who may be a victim or who has information related to the case to contact the Llano County Sheriff’s Office and request to speak with an investigator in the Criminal Investigation Division.

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Grinning suspect cuffed after alleged fiery street takeover, drag race caught on camera

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A driver who allegedly helped wreak havoc during a “reckless” drag-racing street takeover was paraded out of his apartment in handcuffs.

Queens District Attorney Melinda Katz announced the arrest of 22-year-old Asil Assaidi Thursday. Assaidi was charged with reckless endangerment and rioting after a series of “dangerous, fiery driving stunts” near two New York City gas stations April 18.

“Too often there are no consequences in the criminal justice system for this type of outrageous behavior,” New York Police Commissioner Jessica Tisch said. “Clearly, it’s time for that to change.

“My hope and expectation is that Asil Assaidi will be held fully accountable for his actions.”

NYPD INVESTIGATING ‘RECKLESS’ DRAG RACING STREET TAKEOVER IN QUEENS

Assaidi, who grinned widely as he was led out of an NYPD stationhouse on his way to court for his arraignment, did not have any prior arrests, police said. People believed to be his friends were also pictured as the suspect was captured leaving the station.

WATCH: Drag racing suspects cause chaos in NYC street takeover

The district attorney’s office said Assaidi participated in a drag racing street takeover involving more than 100 vehicles in Queens that triggered an NYPD investigation.

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The incident was reported shortly before 2 a.m. near Eliot Avenue and 69th Street, according to the NYPD. One of the participants waved a Palestinian flag out a car window while screeching around the intersection.

When officers arrived, they activated their lights and sirens to disperse the crowd. Dozens of vehicles then fled the area.

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Queens Criminal Court Judge Indira Khan ordered Assaidi to return to court May 14. If convicted of the most serious charge, Assaidi faces up to seven years in prison.

Authorities allege Assaidi was operating a blue Infiniti G37 with a dark hood panel and missing front bumper during the street racing.

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Assaidi, they allege, drove the car in circles around the intersection, nearly colliding with several people standing nearby. Skid marks formed on the road surface and smoke and sparks were produced from the rear end of the car, police said.

An individual poured liquid onto the ground and ignited a ring of flames between Assaidi’s car and the crowd.

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The suspect, authorities allege, repeated the reckless driving with a second driver in a silver vehicle that included a second ring of flames in front of the crowd.

A few people also allegedly jumped on the hood of an NYPD vehicle, causing damage and cracking the windshield before fleeing the scene in a black car.

No injuries were reported in the drag racing incident.

Fox News Digital has reached out to the NYPD for comment.

Fox News Digital’s Landon Mion contributed to this report.

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Family vacation nightmare unfolds with child hospitalized after fall on cruise ship

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A young child was hospitalized after falling on board a cruise ship while it was docked in a popular destination, local media reported.

The 2-year-old fell aboard a TUI Cruises-operated ship, Mein Schiff 7, while it was docked in Funchal, Madeira, according to DN Madeira, a local Portuguese news outlet based in Madeira. The toddler did not appear to fall into the water, according to reports.

Funchal is the capital of the Madeira archipelago, as well as its main port and a popular cruise ship stop.

ANGRY CRUISE PASSENGERS SAY FRUSTRATING ISSUE SHOULD HAVE BEEN DISCLOSED BEFORE BOOKING

The child, whose identity has not been disclosed, was reportedly conscious when responders arrived. The child was with the mother at the time.

Reports said the toddler fell approximately six to 10 feet, reports said.

The circumstances of the fall and where on the ship it took place remain unclear. Authorities have not shared additional details.

The 2-year-old was in “serious condition,” DN Madeira reported, and was sent to the intensive care unit (ICU) of Dr. Nélio Mendonça Hospital.

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TUI Cruises pushed back on reports about the toddler’s condition.

The Germany-based cruise company told Fox News Digital in a statement that the child “was never in a critical condition, nor did [the child] have life-threatening injuries.”

The company said, “We can confirm an incident on Mein Schiff 7 in Madeira involving a child.”

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The child is “in [the] hospital for routine observation,” the spokesperson added.

An isolated island in the Atlantic, Madeira is located some 300 miles north of the Canary Islands and roughly 600 miles southwest of Lisbon, the capital of Portugal.

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It remains a popular vacation destination for its mild year-round climate and rugged coastal cliffs, as well as its namesake fortified wine.

The recent incident follows a string of other cruise-related incidents this year, including accidents during excursions and onboard mishaps.

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