Lee County Sheriff investigates crash injuring pedestrian at University VillageGunshots heard in a Cape Coral neighborhood
Lee County Sheriff investigates crash injuring pedestrian at University Village The Lee County Sheriff’s Office is investigating a crash that injured a pedestrian at the University Village Shops in Lee County.
CAPE CORAL Gunshots heard in a Cape Coral neighborhood Neighbors have reported hearing multiple gunshots in the early hours of the morning in Cape Coral.
SOUTHWEST FLORIDA Tracking the Tropics: Patty forms in North Atlantic, tracking Caribbean development An area in the Southwestern Caribbean has a high, 80% chance of developing over the upcoming week.
SOUTHWEST FLORIDA Warm weekend with spotty showers, daylight saving time ends tonight The Weather Authority says Saturday is starting nice and dry with some passing clouds and pleasant conditions.
WINK NEWS SWFL Scoreboard: High School Football Week 11 The Lehigh Lightning beat the Sarasota Sailors in a Monday night matchup to earn their first win of the season in week 11.
CAPE CORAL Cape Coral man files injunction against city over Jaycee Park A Cape Coral man has filed an injunction against the City of Cape Coral over the renovation of Jaycee Park.
CAPE CORAL Brothers gain highest Boy Scout award for repairing food pantry General Manager of the Adventist Community Services Alexandra Berru said she couldn’t be more grateful for the twin brothers.
2 Vietnam veterans raise $20,000 for monument in Naples Two Vietnam veterans raised over $20,000 to create a Vietnam monument at Cambier Park in Naples.
BONITA SPRINGS Lee County to pick up debris on Estero and Hickory boulevards After three weeks of hard work clearing mountains of sand from Estero and Hickory boulevards, Lee County crews are ready to switch gears to storm debris collection along these main county roads.
SANIBEL Are our habitats on the brink of a slow collapse? For two years, Sanibel Island’s delicate ecosystems have been battered by unrelenting storm surges, leaving behind dead trees and tainted freshwater pools.
LEHIGH ACRES Lehigh Acres driver wants more safety measures for State Road 82 A Lehigh Acres man wants other drivers to know to pay attention. He also wants the county, city or state to put some more patrols out here.
SANIBEL What beaches are experiencing red tide issues now? Parts of Southewst Florida are dealing with red tide. But it’s not impacting Sanibel or beachgoers there.
NAPLES Naples Police Department begins celebrations of 100 years of service The City of Naples Police Department will hit 100 years of service in November of 2025, and they are now beginning their year of celebrations.
ESTERO FGCU students and professor weigh in on upcoming election As the nation gears up for a pivotal election, a question lingers among young voters. Will students turn out to vote?
New procedure helping disc pain Neck pain, shoulder pain, back pain and arm pain can all be caused by a herniated disc. If left untreated, this can become debilitating and lead to nerve damage.
Lee County Sheriff investigates crash injuring pedestrian at University Village The Lee County Sheriff’s Office is investigating a crash that injured a pedestrian at the University Village Shops in Lee County.
CAPE CORAL Gunshots heard in a Cape Coral neighborhood Neighbors have reported hearing multiple gunshots in the early hours of the morning in Cape Coral.
SOUTHWEST FLORIDA Tracking the Tropics: Patty forms in North Atlantic, tracking Caribbean development An area in the Southwestern Caribbean has a high, 80% chance of developing over the upcoming week.
SOUTHWEST FLORIDA Warm weekend with spotty showers, daylight saving time ends tonight The Weather Authority says Saturday is starting nice and dry with some passing clouds and pleasant conditions.
WINK NEWS SWFL Scoreboard: High School Football Week 11 The Lehigh Lightning beat the Sarasota Sailors in a Monday night matchup to earn their first win of the season in week 11.
CAPE CORAL Cape Coral man files injunction against city over Jaycee Park A Cape Coral man has filed an injunction against the City of Cape Coral over the renovation of Jaycee Park.
CAPE CORAL Brothers gain highest Boy Scout award for repairing food pantry General Manager of the Adventist Community Services Alexandra Berru said she couldn’t be more grateful for the twin brothers.
2 Vietnam veterans raise $20,000 for monument in Naples Two Vietnam veterans raised over $20,000 to create a Vietnam monument at Cambier Park in Naples.
BONITA SPRINGS Lee County to pick up debris on Estero and Hickory boulevards After three weeks of hard work clearing mountains of sand from Estero and Hickory boulevards, Lee County crews are ready to switch gears to storm debris collection along these main county roads.
SANIBEL Are our habitats on the brink of a slow collapse? For two years, Sanibel Island’s delicate ecosystems have been battered by unrelenting storm surges, leaving behind dead trees and tainted freshwater pools.
LEHIGH ACRES Lehigh Acres driver wants more safety measures for State Road 82 A Lehigh Acres man wants other drivers to know to pay attention. He also wants the county, city or state to put some more patrols out here.
SANIBEL What beaches are experiencing red tide issues now? Parts of Southewst Florida are dealing with red tide. But it’s not impacting Sanibel or beachgoers there.
NAPLES Naples Police Department begins celebrations of 100 years of service The City of Naples Police Department will hit 100 years of service in November of 2025, and they are now beginning their year of celebrations.
ESTERO FGCU students and professor weigh in on upcoming election As the nation gears up for a pivotal election, a question lingers among young voters. Will students turn out to vote?
New procedure helping disc pain Neck pain, shoulder pain, back pain and arm pain can all be caused by a herniated disc. If left untreated, this can become debilitating and lead to nerve damage.
FILE – A sign for the Food and Drug Administration is displayed outside their offices in Silver Spring, Md., on Dec. 10, 2020. According to research published Sunday, April 7, 2024, in the Journal of the American Medical Association, most cancer drugs granted accelerated approval by the FDA, meant to give patients early access to promising drugs, do not demonstrate such benefits within five years. (AP Photo/Manuel Balce Ceneta, File) The U.S. Food and Drug Administration’s accelerated approval program is meant to give patients early access to promising drugs. But how often do these drugs actually improve or extend patients’ lives? In a new study, researchers found that most cancer drugs granted accelerated approval do not demonstrate such benefits within five years. “Five years after the initial accelerated approval, you should have a definitive answer,” said Dr. Ezekiel Emanuel, a cancer specialist and bioethicist at the University of Pennsylvania who was not involved in the research. “Thousands of people are getting those drugs. That seems a mistake if we don’t know whether they work or not.” The program was created in 1992 to speed access to HIV drugs. Today, 85% of accelerated approvals go to cancer drugs. It allows the FDA to grant early approval to drugs that show promising initial results for treating debilitating or fatal diseases. In exchange, drug companies are expected to do rigorous testing and produce better evidence before gaining full approval. Patients get access to drugs earlier, but the tradeoff means some of the medications don’t pan out. It’s up to the FDA or the drugmaker to withdraw disappointing drugs, and sometimes the FDA has decided that less definitive evidence is good enough for a full approval. The new study found that between 2013 and 2017, there were 46 cancer drugs granted accelerated approval. Of those, 63% were converted to regular approval even though only 43% demonstrated a clinical benefit in confirmatory trials. The research was published in the Journal of the American Medical Association and discussed at the American Association for Cancer Research annual meeting in San Diego on Sunday. It’s unclear how much cancer patients understand about drugs with accelerated approval, said study co-author Dr. Edward Cliff of Harvard Medical School. “We raise the question: Is that uncertainty being conveyed to patients?” Cliff said. Drugs that got accelerated approval may be the only option for patients with rare or advanced cancers, said Dr. Jennifer Litton of MD Anderson Cancer Center in Houston, who was not involved in the study. It’s important for doctors to carefully explain the evidence, Litton said. “It might be shrinking of tumor. It might be how long the tumor stays stable,” Litton said. “You can provide the data you have, but you shouldn’t overpromise.” Congress recently updated the program, giving the FDA more authority and streamlining the process for withdrawing drugs when companies don’t meet their commitments. The changes allow the agency “to withdraw approval for a drug approved under accelerated approval, when appropriate, more quickly,” FDA spokesperson Cherie Duvall-Jones wrote in an email. The FDA can now require that a confirmatory trial be underway when it grants preliminary approval, which speeds up the process of verifying whether a drug works, she said.