Federal regulators declined to approve a nasal spray to treat severe allergic reactions late Tuesday, calling for more research on what would have been the first alternative to injections using devices such as an EpiPen.
The U.S. Food and Drug Administration told ARS Pharmaceuticals Inc., of San Diego, that the company needs to conduct another study on repeat doses of epinephrine, a drug that halts potentially life-threating reactions, called anaphylaxis, using the company's nasal spray device compared with injections.
The move comes four months after an FDA advisory committee recommended approval of the device, dubbed neffy. The FDA is not required to follow the committee's recommendations, though it usually does.
Richard Lowenthal, president and chief executive of ARS, said in a statement that the company would appeal the FDA's decision and resubmit an application in early 2024.
The ARS product is one of several needle-free devices being developed to treat dangerous reactions to food, insect stings and medications. Such a device could alter treatment for the between 33 million and 45 million Americans with severe allergies to food and other triggers.
Advocates for people with allergies said they were “frustrated” by the FDA's request for more research.
“Our community believe this innovation would finally come to the more than 10 per cent of Americans with life-threatening food allergies, but instead, the FDA will force us to wait even longer,” Sung Poblete, chief executive of Food Allergy Research & Education, a nonprofit group, said in a statement.
An election-year roast of U.S. President Joe Biden before journalists, celebrities and politicians at the annual White House correspondents' dinner Saturday.
The 2024 federal budget announced on April 16 included plans to introduce “halal mortgages” as a way to increase access to home ownership.
A recent report sheds light on Canadians living abroad--estimated at around four million people in 2016—and the public policies that impact them.
One person was killed in a six-vehicle crash on Highway 400 in Innisfil Friday evening.
It's one thing to say you like Taylor Swift and her music, but don't blame CNN's AJ Willingham's when she says she just 'doesn't get' the global phenomenon.
Ontario is now home to an invasive and toxic worm species that can grow up to three feet long and can be dangerous to small animals and pets.
Harvey Weinstein’s lawyer said Saturday that the onetime movie mogul has been hospitalized for a battery of tests after his return to New York City following an appeals court ruling nullifying his 2020 rape conviction.
Polish President Andrzej Duda says while no decision has been made around whether Poland will host nuclear weapons as part of an expansion of the NATO alliance’s nuclear sharing program, his country is willing and prepared to do so.
A number of LGBQT+2s groups in Central Alberta are pushing back against a request from the Red Deer South UCP constituency to reinstate MLA Jennifer Johnson into the UCP caucus.
Out of more than 9,000 entries from over 2,000 breweries in 50 countries, a handful of B.C. brews landed on the podium at the World Beer Cup this week.
Several students have launched an encampment at McGill University as they call on the institution to cut financial ties with Israel.
A number of LGBQT+2s groups in Central Alberta are pushing back against a request from the Red Deer South UCP constituency to reinstate MLA Jennifer Johnson into the UCP caucus.
A recent report sheds light on Canadians living abroad--estimated at around four million people in 2016—and the public policies that impact them.
One person was killed in a six-vehicle crash on Highway 400 in Innisfil Friday evening.
The lawyer for a residential school survivor leading a proposed class-action defamation lawsuit against the Catholic Church over residential schools says the court action is a last resort.
An election-year roast of U.S. President Joe Biden before journalists, celebrities and politicians at the annual White House correspondents' dinner Saturday.
Harvey Weinstein’s lawyer said Saturday that the onetime movie mogul has been hospitalized for a battery of tests after his return to New York City following an appeals court ruling nullifying his 2020 rape conviction.
Iraqi authorities on Saturday were investigating the killing of a well-known social media influencer, who was shot by an armed motorcyclist in front of her home in central Baghdad.
As students protesting the Israel-Hamas war at universities across U.S. dug in Saturday and vowed to keep their demonstrations going, some universities shut down encampments after reports of antisemitic activity among the protesters.
The 75-year-old British monarch will slowly ease back into public life after a three-month break to focus on his treatment and recuperation after he was diagnosed with an undisclosed type of cancer.
The first criminal prosecution of a former president began in earnest with opening statements and testimony in a lower Manhattan courtroom. But the action quickly spread to involve more than half a dozen cases in four states and the nation's capital. Twice during the week, lawyers for Trump were simultaneously appearing in different courtrooms.
Polish President Andrzej Duda says while no decision has been made around whether Poland will host nuclear weapons as part of an expansion of the NATO alliance’s nuclear sharing program, his country is willing and prepared to do so.
Sophie Gregoire Trudeau says there is 'still so much love' between her and Prime Minister Justin Trudeau, as they navigate their post-separation relationship co-parenting their three children.
Ottawa has plans to finally stop blocking Canadian development aid to Afghanistan this year.
A Sherwood Park family says their new house is uninhabitable. The McNaughton's say they were forced to leave the house after living there for only a week because contaminants inside made it difficult to breathe.
Breast cancer rates are rising in Canada among women in their 20s, 30s and 40s, according to research by the University of Ottawa (uOttawa).
More than 115 people who viewed the solar eclipse in Ontario earlier this month experienced eye damage after the event, according to eye doctors in the province.
State-sponsored actors targeted security devices used by governments around the world, according to technology firm Cisco Systems, which said the network devices are coveted intrusion points by spies.
TikTok is in the crosshairs of authorities in the U.S., where a new law threatens a nationwide ban unless its China-based parent ByteDance divests. Here are the places that have partial or total bans on TikTok.
The Hubble Space Telescope has captured a stunning new image of the glowing gas ejected from a dying star, which in this case happens to resemble a 'cosmic dumbbell.'
Harvey Weinstein’s lawyer said Saturday that the onetime movie mogul has been hospitalized for a battery of tests after his return to New York City following an appeals court ruling nullifying his 2020 rape conviction.
Taking place in May in Malmo, Sweden, the 68th annual competition will see acts from 37 countries vie for the continent’s pop crown in a feelgood extravaganza that strives — not always successfully – to banish international strife and division. And you don’t have to be in Europe to watch, or to help pick the winner.
It's one thing to say you like Taylor Swift and her music, but don't blame CNN's AJ Willingham's when she says she just 'doesn't get' the global phenomenon.
The 2024 federal budget announced on April 16 included plans to introduce “halal mortgages” as a way to increase access to home ownership.
The federal and Quebec governments are spending close to $100 million to boost the country's manufacturing capacity for semiconductors, which are vital in technologies ranging from artificial intelligence to quantum computing.
The number of vacant jobs in Canada increased in February, while monthly payroll employment decreased in food services, manufacturing, and retail trade, among other sectors.
Take an illustrated look back at the culinary history of Winnipeg.
An idyllic 453-acre private island is up for sale off the west coast of Scotland and it comes with sandy beaches, puffins galore, seven houses, a pub, a helipad and a flock of black-faced sheep.
During a special winner celebration near their hometown, Doug and Enid shared the story of how they discovered they were holding a Lotto Max ticket worth $70 million and how they kept this huge secret for so long.
Mookie Betts went 3 for 5, including a triple and an RBI single, as the Los Angeles Dodgers beat the Toronto Blue Jays 4-2 on Saturday.
Canadian football observers thought it could happen, and on Saturday, it did. Towering offensive lineman Giovanni Manu – who was born in Tonga and grew up in Pitt Meadows, B.C. – became the first player from the University of British Columbia ever to be selected in the NFL draft.
William Nylander has joined the Stanley Cup chase.
An Ontario man who took out a loan to pay for auto repairs said his car was repossessed after he missed two payments.
Ford’s electric vehicle unit reported that losses soared in the first quarter to US $1.3 billion, or US$132,000 for each of the 10,000 vehicles it sold in the first three months of the year.
Honda is set to build an electric vehicle battery plant next to its Alliston, Ont., assembly plant, which it is retooling to produce fully electric vehicles, all part of a $15-billion project that is expected to include up to $5 billion in public money.
As if a 4-0 Edmonton Oilers lead in Game 1 of their playoff series with the Los Angeles Kings wasn't good enough, what was announced at Rogers Place during the next TV timeout nearly blew the roof off the downtown arena.
Mounties in Nanaimo, B.C., say two late-night revellers are lucky their allegedly drunken antics weren't reported to police after security cameras captured the men trying to steal a heavy sign from a downtown business.
A property tax bill is perplexing a small townhouse community in Fergus, Ont.
When identical twin sisters Kim and Michelle Krezonoski were invited to compete against some of the world’s most elite female runners at last week’s Boston Marathon, they were in disbelief.
The giant stone statues guarding the Lions Gate Bridge have been dressed in custom Vancouver Canucks jerseys as the NHL playoffs get underway.
A local Oilers fan is hoping to see his team cut through the postseason, so he can cut his hair.
A family from Laval, Que. is looking for answers... and their father's body. He died on vacation in Cuba and authorities sent someone else's body back to Canada.
A former educational assistant is calling attention to the rising violence in Alberta's classrooms.
The federal government says its plan to increase taxes on capital gains is aimed at wealthy Canadians to achieve “tax fairness.”
Out of more than 9,000 entries from over 2,000 breweries in 50 countries, a handful of B.C. brews landed on the podium at the World Beer Cup this week.
The special teams unit has become a strength for the Canucks, particularly in the first-round playoff series against the Nashville Predators which the Canucks lead 2-1 heading into Sunday's Game 4.
Canadian football observers thought it could happen, and on Saturday, it did. Towering offensive lineman Giovanni Manu – who was born in Tonga and grew up in Pitt Meadows, B.C. – became the first player from the University of British Columbia ever to be selected in the NFL draft.
One person has been charged with second-degree murder in connection with the death of a man who fell from a balcony following an altercation inside a Toronto apartment building.
Ontario is now home to an invasive and toxic worm species that can grow up to three feet long and can be dangerous to small animals and pets.
William Nylander has joined the Stanley Cup chase.
It was a long-awaited reunion at the Calgary International Airport Saturday as Ossama Zaqqout hugged his parents, who had just arrived after fleeing the war in Gaza.
A blue SUV and a motorbike collided Saturday afternoon in the Beltline.
One Siksika Nation resident has been charged and an arrest warrant for a second man has been issued in relation to an April 24 homicide in Gleichen.
The 2024 federal budget announced on April 16 included plans to introduce “halal mortgages” as a way to increase access to home ownership.
The Ottawa Police Service says a 47-year-old woman is facing charges following a series of hate crimes in the downtown area last week.
The Ontario Provincial Police (OPP) asked drivers to expect delays after a single-vehicle collision on Highway 15 near Brewers Mills Road Saturday morning.
Several students have launched an encampment at McGill University as they call on the institution to cut financial ties with Israel.
Montreal says public transit trips were up between 15 and 20 per cent among people age 65 and over in the six months after it made the service free for local seniors.
Quebec provincial police say a 51-year-old woman has died after a head-on collision in the town of Lachute, roughly 50 kilometres west of Montreal, early this morning.
Kris Knoblauch is five months into watching Connor McDavid and Leon Draisaitl go to work.
Two years and $8 million worth of beds, couches, dishes and dressers later, the Ukrainian Newcomer Free Furniture Warehouse is closing its doors.
A Sherwood Park family says their new house is uninhabitable. The McNaughton's say they were forced to leave the house after living there for only a week because contaminants inside made it difficult to breathe.
A Toronto-based restructuring firm says several bidders have offered to buy all or part of SaltWire Network and The Halifax Herald, the two insolvent companies that operate Atlantic Canada's largest newspaper enterprise.
Halifax’s professional soccer team kicks off its sixth season against Ottawa on Saturday with a sold-out crowd of 6,500 fans on the Wanderers Grounds.
“This is the largest year we’ve had”: annual provincial strongman competition sees record levels of participation and support with 55 athletes taking part
The trial for the man accused of killing four Indigenous women in Winnipeg is set to get underway on April 29.
A Winnipeg scale model builder is using his craft to showcase a large piece of Canadian history in miniature form.
With heavy wind gusts expected along Lake Manitoba and Lake Winnipeg this weekend, the provincial government is warning residents and property owners about potential ice pileups.
'Feel through the Deepness to see,' an art installation by artist Rita McKeough, will be calling the Dunlop Art Gallery home for the next two months.
Regina's annual model train showcase rolled into town this weekend at the Caledonian Curling Club.
The team of Commissionaires at The Regina Public Library’s downtown branch have received one of the organization’s top honours.
Raneem, 10, lives with a neurological condition and liver disease and needs Cholbam, a medication, for a longer and healthier life.
A driver has been arrested and a pedestrian has been seriously injured following a hit-and-run crash in Cambridge.
Rainy weather for the second year in a row once again did not deter attendees from a special fundraising event.
Workers at group homes run by LutherCare Communities in Saskatoon are escalating their strike action.
On Saturday, in a display of cross-cultural solidarity, members of the Indigenous and Palestinian communities gathered in Saskatoon for an event steeped in prayer and dance.
The Saskatoon Police Service (SPS) and Saskatchewan Coroners Service are investigating after a woman’s body was found at a recycling facility Friday morning.
Environment Canada issued a severe thunderstorm watch for several communities in northeastern Ontario on Saturday afternoon – primarily the Greater Sudbury area and West Nipissing.
One person was killed in a six-vehicle crash on Highway 400 in Innisfil Friday evening.
The Municipality of French River has been under a flood watch since Thursday evening and many residents told CTV News that they fear the already high water levels combined with the rain forecasted in the coming days may cause more widespread flooding.
A 24-year-old man who died Friday in a car crash on Highway 401 has been identified as Omar Barzak from London, Ont.
London’s Victoria Park was filled with colours Saturday afternoon as those attending Holi threw coloured water and powders into the air in a celebration of spring and unity.
At an event in which she was celebrated for her advocacy of women’s issues, Karen Vecchio was in no mood to speak about her removal from her role of chair of Federal Parliament’s Status of Women Committee.
One person was killed in a six-vehicle crash on Highway 400 in Innisfil Friday evening.
Police in Meaford are investigating after a senior drowned Saturday morning.
Despite the poor weather, a festival celebrating all things maple syrup drew thousands of people to Elmvale on Saturday.
A former graduate of Holy Names Catholic High School in Windsor will soon be moving to New York after being selected during the 2024 NFL Draft.
Playing bingo in April made a local resident $100,000 richer -- and will keep him in his home.
Campus police are investigating after homophobic slurs were carved into the door of the University of Windsor’s Campus Pride Centre earlier this month.
Out of more than 9,000 entries from over 2,000 breweries in 50 countries, a handful of B.C. brews landed on the podium at the World Beer Cup this week.
J.T. Miller had a goal and assist and the Vancouver Canucks edged the Nashville Predators 2-1 to re-take the lead in their first-round playoff series.
The lawyer for a residential school survivor leading a proposed class-action defamation lawsuit against the Catholic Church over residential schools says the court action is a last resort.
Out of more than 9,000 entries from over 2,000 breweries in 50 countries, a handful of B.C. brews landed on the podium at the World Beer Cup this week.
An emaciated dachshund is now recovering thanks to a Good Samaritan who found the pup near a biking trail in Kelowna, according to the BC SPCA.
Search and rescue crews have been called in after a vehicle belonging to a missing senior was located near a rural intersection outside of Kelowna Tuesday.
The Brooks Bandits got down to business Friday, defeating the Okotoks Oilers 8-2.
An Alberta political scientist said the NDP leadership hopefuls remained fairly even following the first of the party’s debates.
It was a busy Wednesday evening for fire crews in Lethbridge County after multiple grass fires were sparked near the Kipp rail yard.
St. Joseph’s General Hospital Elliot Lake says it is moving towards “normalcy” by transitioning to a mask-friendly policy.
Environment Canada issued a severe thunderstorm watch for several communities in northeastern Ontario on Saturday afternoon – primarily the Greater Sudbury area and West Nipissing.
About 100 delegates from around the province travelled to Timmins, Ont., for its annual general meeting and convention at Cedar Meadows Resort and Spa.
Legendary sportscaster Bob Cole was a Newfoundlander through and through, and his daughter says his connection to the province was 'everything' to him.
Cenovus Energy has been ordered to pay a $2.5-million fine for its role in the largest offshore oil spill ever recorded in Newfoundland and Labrador.
As more Canadians find themselves struggling to afford or find housing, the country's smallest province is the only one that can point to legislation recognizing housing as a human right.
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