Barefoot workers and cracked floors were found at a factory that made recalled eyedrops, FDA says
U.S. health inspectors found a host of sanitation and manufacturing problems at an Indian plant that recently recalled eyedrops sold in the U.S. The problems include cracked floors, barefoot workers and manipulated testing records.
FDA says it needs more research before deciding to approve nasal spray to treat dangerous allergies
The U.S. Food and Drug Administration declined to approve a nasal spray to treat severe allergic reactions, calling for more research on what would have been the first alternative to injections using devices such as an EpiPen.
FDA warns consumers not to use off-brand versions of Ozempic, Wegovy
The U.S. Food and Drug Administration is warning consumers not to use versions of the popular weight-loss drug used in Ozempic and Wegovy and sold online because they might not contain the same ingredients as prescription products and may not be safe or effective.
Vermont governor signs shield bills that protect providers who offer medicated abortion
Vermont’s Republican governor has signed abortion and gender affirmed shield bills into law that include protecting access to a medication widely used in abortions even if the U.S. Food and Drug Administration withdraws its approval of the pill, mifepristone.
Vermont passes bills aimed at protecting abortion pills
The Vermont Legislature has passed reproductive and gender-affirming health care bills with a late addition aimed at protecting access to a medication widely used in abortions — even if the U.S. Food and Drug Administration withdraws its approval of mifepristone.
FDA recommends people perform repeat or serial testing when taking at-home COVID-19 tests to reduce risk of false negative results
The FDA says if repeat testing is not performed after a negative result, an infection may be missed and people may unknowingly spread the SARS-CoV-2 virus to others, especially if they are not experiencing symptoms.
COVID-19 booster: This is everything we know so far about the extra dose approved by the FDA
Transplant recipients and others with severely weakened immune systems can get an extra dose of the Pfizer or Moderna COVID-19 vaccines to better protect them as the delta variant continues to surge across the U.S., federal regulators said Thursday.
FDA letter calls out Amazon for products with harmful ingredients
The U.S. Food and Drug Administration (FDA) has warned Amazon of 30 sexual enhancement and weight loss supplements sold on its website that contained “undeclared and potentially harmful drug ingredients,” according to a letter sent to the company.
Check your pantry: 26 muffin products under nationwide recall due to possible listeria contamination, FDA says
Give and Go Prepared Foods (U.S.A.) Corp. announced a voluntary nationwide recall of certain muffin products Thursday due to the potential for the products to be contaminated with Listeria, according to the U.S. Food and Drug Administration.
Houston-based company receives FDA for use of Rapid Acoustic Pulse technology to reduce cellulite appearance
HOUSTON – Soliton, a Houston-based company, has been granted approval by the U.S. Food and Drug Administration (FDA) for its technology that can purportedly blast away cellulite. According to a news release from the company, its new Rapid Acoustic Pulse (RAP) technology works with soundwaves to reduce the appearance of cellulite. “We’re thrilled to receive this latest clearance for our RAP technology,” Soliton president and CEO Brad Hauser said. AdThe new innovation derives from Soliton’s tattoo removal device that treats the skin with up to 100 waves per second. The company first received FDA approval for using RAP technology for tattoo removal in 2019, according to the release.
The Latest: Chinese, Russian vaccines to arrive in Mexico
Health officials say the first shipments of the Chinese and Russian vaccines will be used in low-income neighborhoods of Mexico City or its suburbs. — Millions of vulnerable U.S. residents will need COVID-19 vaccines brought to them because they rarely or never leave their homes. Johnson & Johnson in December agreed to provide up to 500 million doses of its vaccine to COVAX through 2022. Ad“If we are to end the global pandemic, life-saving innovations like vaccines must be within reach for all countries,” Johnson & Johnson Chief Scientific Officer Dr. Paul Stoffels said in a statement. The state health department has scheduled vaccination clinics during the weekend to replace those postponed due to a winter storm.
Congress, LA take divergent paths after COVID test warning
The U.S. Food and Drug Administration is warning patients and health care providers that a coronavirus test developed by California company Curative may produce false results. (AP Photo/Ted S. Warren, File)LOS ANGELES – Los Angeles will continue using a coronavirus test that federal regulators warned may produce false results while Congress, which has used the same test, is seeking an alternative. He said a third of the city's positive test results have been in asymptomatic people. No test is 100% accurate and even the most sensitive are expected to deliver a small percentage of false results. He wasn’t concerned that bad test results were contributing to the exponential spread of the virus in the county.
White House threatens Hahn’s job over vaccine approval
The FDA granted emergency use for the vaccine produced by Pfizer Inc. and its German partner BioNTech. Friday’s threat marked the latest attempt by the Trump administration to override government scientists working to combat the deadly pandemic. “Get the dam vaccines out NOW, Dr. Hahn,” Trump tweeted Friday. Hahn told The Associated Press earlier this week that his agency had already teed up authorization by prefilling all the necessary legal paperwork. “We’re doing everything we can to cut down on the red tape, which I think is really important,” Hahn told the AP.
The Latest: US gives go-ahead for Pfizer coronavirus vaccine
This October 2020 photo provided by Pfizer shows freezers set up in a warehouse in Kalamzoo, Mich., in preparation for distribution of the company's coronavirus vaccine. ___THE VIRUS OUTBREAK:The White House is pressuring the FDA chief Stephen Hahn to grant an emergency use authorization for Pfizer’s coronavirus vaccine by the end of the day. Andrew Cuomo has reinstated indoor dining restrictions indefinitely in New York City in an effort to limit the increase in coronavirus cases and hospitalizations. Michigan’s health department argues the teaching restriction is necessary to control the spread of the coronavirus, especially after Thanksgiving gatherings. State Health Department officials on Friday confirmed 513 new cases of the coronavirus.
Thousands of Texas healthcare providers enrolled to distribute COVID-19 vaccine
HOUSTON – State health officials said more than 5,000 healthcare providers have enrolled with the Texas Department of State Health Services to distribute the COVID-19 vaccine. Texas’ Expert Vaccine Allocation Panel is working on who will be among the next to receive the vaccine. Only documented healthcare providers who’ve enrolled with the state can receive the vaccine. Healthcare providers also had to prove they could store the Pfizer vaccine at sub-zero temperatures. Texas’ first-week allotment schedule shows the nearly 225,000 doses will be sent to 109 healthcare providers in 34 counties.
The Latest: Australia leader to go slow on Pfizer vaccine
If approved, shots could begin within days for health care workers and people in nursing homes. Shots would then begin for health care workers and nursing home residents. ___CANBERRA, Australia — Australian researchers say they have abandoned development of a potential coronavirus vaccine because it produced false positive results on HIV tests. A health ministry statement says the government will first vaccinate health care workers, particularly those who deal with COVID-19 cases. ___HONOLULU — Hawaii expects to receive 80,000 doses of coronavirus vaccine in December for health care workers and residents of long-term care facilities.
The Latest: Hong Kong re-imposes restaurant dining bans
Hong Kong on Wednesday reported an additional 100 cases, bringing its two-week total to 1,274. Hong Kong has reported a total of 7,075 confirmed cases since the start of the pandemic, with 112 deaths. The Texas Department of State Health Services also said 9,028 people were hospitalized across the state. Since late November, the new daily cases have soared past 10,000 on several days, with 15,103 new cases reported Tuesday, according to state health officials. ___BOISE, Idaho — Idaho public health officials abruptly ended a meeting Tuesday evening after the Boise mayor and chief of police said intense anti-mask protests outside the health department building — as well as outside some health officials’ homes — were threatening public safety.
Britain OKs Pfizer vaccine and will begin shots within days
In giving the go-ahead for emergency use of the vaccine developed by American drugmaker Pfizer and Germany’s BioNTech, Britain vaulted past the United States by at least a week. Officials cautioned that several tough months still lie ahead even in Britain, given the monumental task of inoculating large swaths of the population. Hancock said Britain will begin receiving the first shipment of 800,000 doses from Belgium within days, and people will start getting the shots as soon as it arrives. Still to be determined is whether the Pfizer-BioNTech shots prevent people from spreading the virus when they have no symptoms. ___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education.
The Latest: Hawaii imposes new COVID-19 travel restrictions
There were 1,225 new confirmed COVID-19 cases increasing the state total to 60,873. ___WASHINGTON -- Pharmaceutical companies Pfizer and BioNTech will seek emergency government approval for their coronavirus vaccine, as the U.S. aims to begin administering doses by the end of the year. ___LOUISVILLE, Kentucky — Kentucky reported a new daily record of 3,649 coronavirus cases Thursday amid warnings by Gov. He and public health experts are warily watching the number of patients hospitalized with the COVID-19 disease caused by the coronavirus. ___WASHINGTON — Infection disease expert Dr. Anthony Fauci says he “wants to settle” concerns about a coronavirus vaccine as he returns to the White House podium for the first time in months.
The Latest: S Korea begins stronger limits in some areas
In September, the district reported about 13 new coronavirus cases weekly, mostly involving teachers and staff, when it first opened early childhood education classes. ___ST. PETERSBURG, Fla. — Five Florida mayors are expressing concern about the rising number of coronavirus cases in the state, and are urging Gov. But the state’s rolling seven-day average for new coronavirus cases was more than nine times higher Wednesday than it was than when her first order took effect. Officials began instituting local shutdowns in neighborhoods where coronavirus cases were rapidly rising. There were 5,102 cases reported in Minnesota on Wednesday, along with 67 deaths.
Court orders FDA to assess environmental impact of GM salmon
The ruling by U.S. District Court Judge Vince Chhabria in San Francisco centers on AquaBounty’s salmon, which are genetically modified to grow faster than normal salmon. In 2015, the fish became the first genetically modified animal approved for human consumption in the U.S. After clearing other regulatory hurdles. To ensure the fish do not escape and breed with wild fish, Massachusetts-based AquaBounty says its salmon are raised in tanks and bred to be female and sterile. In his ruling, Judge Chhabria noted that the FDA determined the probability of the salmon escaping and surviving in the wild to be quite low. The salmon already has been sold in limited quantities in Canada, where it doesn’t have to be labeled as genetically modified, the company has said.
Lilly antibody drug fails in a COVID-19 study; others go on
U.S. government officials are putting an early end to a study testing an Eli Lilly antibody drug for people hospitalized with COVID-19 because it doesn’t seem to be helping them. Independent monitors had paused enrollment in the study two weeks ago because of a possible safety issue. In a statement Lilly notes that the government is continuing a separate study testing the antibody drug in mild to moderately ill patients, to try to prevent hospitalization and severe illness. The company also is continuing its own studies testing the drug, which is being developed with the Canadian company AbCellera. Lilly and Regeneron have asked the U.S. Food and Drug Administration to grant emergency use authorization for their drugs for COVID-19 while late-stage studies continue.
FDA approves first COVID-19 drug: antiviral remdesivir
U.S. regulators on Thursday approved the first drug to treat COVID-19: remdesivir, an antiviral medicine given to hospitalized patients through an IV. It had been authorized for use on an emergency basis since spring, and now becomes the first drug to win full Food and Drug Administration approval for treating COVID-19. For patients younger than 12, the FDA will still allow the drug’s use in certain cases under its previous emergency authorization. The drug is either approved or has temporary authorization in about 50 countries, he noted. The FDA also has given emergency authorization to using the blood of survivors, and two companies are currently seeking similar authorization for experimental antibody drugs.
US regulators seek advice on thorny issues as vaccines near
The U.S. Food and Drug Administration will hold a meeting to discuss the process of approving COVID-19 vaccines. The panelists generally supported guidelines for the vaccines that the FDA recently issued, over White House objections. A recent poll by The Associated Press shows only 46% of those surveyed want to get a COVID-19 vaccine and another 29% are unsure. So the government is planning extra scrutiny of every COVID-19 vaccine to hit the market. ___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education.
Warning for parents about children overdosing in ‘Benadryl challenge'
Some teens and children are intentionally overdosing on the antihistamine, Benadryl, as part of a “challenge” on Tik Tok. While the social media platform has pledged to remove videos publicizing it, local doctors and the Food and Drug Administration are warning parents about ways to recognize if your child is doing this. We are aware of news reports of teenagers ending up in emergency rooms or dying after participating in the “Benadryl Challenge” encouraged in videos posted on the social media application TikTok. BENADRYL® products and other diphenhydramine products should only be used as directed by the label. The most common way people overdoseOne toxicologist said Benadryl is the most common over-the-counter drug to overdose on.
US regulators approve 1st treatment for Ebola virus
On Wednesday, the U.S. Food and Drug Administration said it has approved the drug for treating Ebola in both adults and children. (Regeneron via AP)U.S. regulators Wednesday approved the first drug for the treatment of Ebola. The Food and Drug Administration OK'd the drug developed by Regeneron Pharmaceuticals for treating adults and children with the Zaire Ebola virus strain, the most deadly of six known types. Regeneron's treatment is a combination of three antibodies that work by killing the virus. After four weeks, about a third of those who got Regeneron's drug had died.