STAT

JUNE 9, 2023

The group voted 6-0 that an 1,800-patient study of Leqembi confirmed its benefits for patients in the early stages of Alzheimer’s, recommending the FDA widen the drug’s limited approval. The agency, which is not required to follow the suggestions of its advisers, is expected to make a final decision on Leqembi by July 6.

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FDA Hospitals 144

pharmaphorum

NOVEMBER 16, 2021

An artificial intelligence algorithm developed by GE Healthcare that helps with the placement of endotracheal tubes (ETTs) has been approved by the FDA. The algorithm, which according to GE is the first to be approved by the FDA for this application, is used on a mobile X-ray device.

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STAT

JUNE 25, 2024

The 12-lead electrocardiogram device, called the Kardia 12L ECG System, is a hand-held version of the standard ECG device usually found in hospitals and used to diagnose heart conditions.

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FDA Documentation Hospitals 140

STAT

JUNE 17, 2024

The vaccine, which will be sold under the name Capvaxive, is designed to protect against pneumococcal pneumonia, which hospitalizes about 150,000 adults in the United States every year and kills about 1 in 20 who develop it, according to the National Foundation for Infectious Diseases. Read the rest…

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Vaccines FDA Hospitals 145

STAT

NOVEMBER 28, 2023

“Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory action,” the agency said in a statement.

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FDA Hospitals 145

IDStewardship

APRIL 14, 2024

These advancements are evidenced by the two FDA-approved FMT products available for rCDI prevention: Rebyota (Fecal Microbiota, Live-jslm) and Vowst (Fecal Microbiota Spores, Live-brpk). Rebyota, a solution delivered via enema, was the first FMT product to be FDA-approved. Am J Gastroenterol. Jain N, Umar TP, Fahner AF, Gibietis V.

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FDA Hospitals Communication 331

STAT

JANUARY 4, 2024

At issue is the Research, Abuse, Diversion, and Addiction-Related Surveillance system, or RADARS, which was originally created as in-house monitoring program by Purdue Pharma and later sold to the Denver Health and Hospital Authority. Continue to STAT+ to read the full story…

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STAT

MARCH 18, 2025

I self-referred for GLP-1s years ago after seeing advertisements, and even though I am a diabetic, what followed were horrific health outcomes: hospitalizations, extensive procedures, scans, MRIs, pancreatitis, anemia, and thousands in medical expenses. So I understand why new Health and Human Services Secretary Robert F. Kennedy Jr.

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Hospitals FDA 98

Pharmacy Times

NOVEMBER 30, 2023

Drug reaction with eosinophilia and systemic symptoms can start as a rash and quickly progress, affecting the internal organs and requiring hospitalization, even resulting in death.

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Hospitals FDA 145

pharmaphorum

JUNE 30, 2022

The FDA’s decision not to approve Spero Therapeutics’ oral antibiotic tebipenem Hbr for adults with complicated urinary tract infections (cUTI) further increases the threat of antibiotic resistance, according to a GlobalData analyst.

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FDA Hospitals 119

STAT

APRIL 27, 2023

In public, hospitals rave about artificial intelligence. They trumpet the technology in press releases, plaster its use on billboards, and sprinkle AI into speeches touting its ability to detect diseases earlier and make health care faster, better, and cheaper. But on the front lines, the hype is smashing into a starkly different reality.

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Hospitals FDA 116

STAT

SEPTEMBER 11, 2024

  Developers can’t fully guarantee the algorithm’s performance, explained Califf, because an AI model’s performance evolves over time and performs differently in different hospitals’ patient populations, unlike a drug. And that model drift is “happening in health systems.

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Hospitals FDA 144

STAT

NOVEMBER 9, 2022

An FDA advisory panel voted 5-to-8 to recommend rejecting a new drug for patients hospitalized with Covid-19, ruling that a glimmer of potential life-saving benefit couldn’t make up for a long list of questions around the company’s main trial. 

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FDA Hospitals 102

STAT

JULY 25, 2024

Tara Bannow, our hospitals and insurance reporter, joins us to talk about a new investigation that shows how UnitedHealth wields its unrivaled physician empire to boost its profits and expand its influence. Is Viking Therapeutics an attractive acquisition target? And is Adam good at math?

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Insurance FDA Hospitals 118

STAT

JUNE 24, 2024

Once FDA regulators decide a device is safe and effective, companies and researchers then attempt to track how the device performs in the real world. This makes it incredibly difficult for researchers to observe device performance trends in claims data, and for hospitals to reach out to patients when specific devices are recalled.

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Insurance Hospitals FDA 135

Pharmacy Times

MAY 9, 2023

Dapagliflozin was established as the first SGLT2 inhibitor that demonstrated a mortality benefit for cardiovascular death from heart failure.

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Labelling Hospitals FDA 123

STAT

SEPTEMBER 19, 2023

A team at the Children’s Hospital of Philadelphia, led by Alan Flake, is the closest to human trials — their device is a bag filled with sterile fluid, which contains the fetus and is connected to tubes providing oxygen and nutrition.

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FDA Hospitals 145

Digital Pharmacist

OCTOBER 26, 2022

Food and Drug Administration (FDA) announced its approval of the Boostrix vaccine, commonly known as Tdap (combination of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis) for immunization administration during the third trimester of pregnancy to prevent pertussis in infants younger than two months of age.

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Pharmacy Times

DECEMBER 22, 2022

Intravenous tocilizumab (Actemra; Genentech) has been approved for the treatment of COVID-19 in individuals who are hospitalized and receiving systemic corticosteroids and supplemental oxygen.

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Hospitals FDA 123

Hospital Pharmacy Europe

MARCH 6, 2023

Following the FDA approval, the company has created the Reata Education, Access, and Care Helpline ( REACH ), an integrated specialty pharmacy and patient services program, designed to help eligible patients access prescribed Reata medicines.

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FDA Specialty Pharmacies Labelling Hospitals 97

STAT

AUGUST 23, 2023

  The panel, whose advice the FDA typically follows, voted that the system developed by ReCor Medical was safe and effective. Luke’s Hospital of Kansas City, said regarding Medtronic’s device. It voted that the benefits of a system developed by Medtronic, however, did not outweigh the risks.

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FDA Hospitals 98

pharmaphorum

MAY 25, 2022

After more than six years of development, Angle has scored an FDA approval for Parsortix as a diagnostic for metastatic breast cancer – the first ever in the US for a device used to detect cancer by harvesting cells from a patient blood sample. The post Angle claims FDA okay for Parsortix liquid biopsy system appeared first on.

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STAT

JULY 31, 2024

Mount Sinai, a leading hospital network in New York City, has mounted an extraordinary behind-the-scenes campaign to blunt the fallout over revelations about its controversial research project in which brain biopsies are taken from patients undergoing deep brain stimulation, STAT has learned.

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Documentation FDA Hospitals 145

STAT

DECEMBER 29, 2023

Department of Agriculture estimates 2,000 hospitalizations and 150 deaths in the U.S. Each year, 200,000 Americans require emergency medical care for allergic reactions to food; every three minutes, food allergies send someone to the emergency room. due to allergic reactions to food every year. Read the rest…

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FDA Hospitals 140

Pharmaceutical Technology

MAY 29, 2023

Lexicon Pharmaceuticals (Lexicon) has received approval from the US Food and Drug Administration (FDA) for its Inpefa drug to treat heart failure. Inpefa is a once-daily oral tablet indicated as an inhibitor of sodium-glucose co-transporter type 2 (SGLT2) and type 1 (SGLT1).

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FDA Labelling Hospitals 98

Pharmacy Times

JULY 7, 2022

Paxlovid treats COVID-19 in adults and children [12 years of age and older weighing at least 88 pounds (40 kg)] with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

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Hospitals FDA 123

The Checkup by Singlecare

FEBRUARY 4, 2025

Food and Drug Administration (FDA) to manage Type 2 diabetes mellitus. A study was designed to compare the use of Invokana (canagliflozin), another SGLT2 inhibitor, or Farxiga with Jardiance for occurrence of myocardial infarction (MI) or stroke, or heart failure hospitalization. Each has additional specific uses as described below.

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Hospitals Insurance Adverse Reactions Insurance Coverage 52

STAT

JANUARY 23, 2024

The FDA said it considered the risks of T-cell malignancy, which refers to a group of blood disorders including lymphoma and leukemia, resulting in hospitalization and death, to be applicable to all therapies in the category. Since  Since 2017, six CAR-T cell therapies have been approved by the FDA.

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FDA Hospitals 110

STAT

APRIL 19, 2023

The result was scores of infants and toddlers in need of hospitalization, greatly exceeding the capacities of our nation’s hospitals.

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Vaccines Hospitals FDA 98

STAT

SEPTEMBER 17, 2024

Panelists include leaders from the Food and Drug Administration, the Centers for Disease Control and Prevention, a Harvard Medical School teaching hospital, and electronic health record giant Epic Systems.

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Medical Schools FDA Hospitals 134

The Checkup by Singlecare

DECEMBER 26, 2024

Over 40 new medications have been approved by the FDA, giving patients more options for treating various health problems. Zelsuvmi (berdazimer) Zelsuvmi received the green light from the FDA on January 5, 2024. Zelsuvmi’s approval is a big deal because it’s only the second FDA-approved treatment for this condition.

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FDA Dosage Immunization Hospitals 52

STAT

DECEMBER 18, 2023

Her son, Declan, who turns 2 years old in January, survived a life-threatening episode of cardiac arrest that sent him to a hospital emergency room a year ago. Jamie Dubuque faces the future with a mixture of gratitude and trepidation.

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Hospitals FDA 143

STAT

OCTOBER 2, 2023

Critical information, like unique device identifiers that help hospitals keep track of implants in patients, was often missing. She quickly realized that the software was too old and clunky to identify report patterns that would help the agency shut down a product before hurting patients.

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Insurance FDA Hospitals 128

Hospital Pharmacy Europe

FEBRUARY 23, 2023

The post FDA approves Syfovre for geographic atrophy in advanced age-related macular degeneration appeared first on Hospital Pharmacy Europe. Geographic atrophy (GA) is an advanced form of age-related macular degeneration and which leads to progressive and irreversible loss of vision.

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FDA Immunization Hospitals 98

The Checkup by Singlecare

MARCH 31, 2025

Ozempic and Wegovy (and Rybelsus , which is oral semaglutide) are GLP-1 receptor agonists (glucagon-like peptide-1 receptor agonists, commonly referred to as GLP-1s) and are the only FDA-approved drugs that contain the active ingredient semaglutide. Some facilities add B12 to their compounds, in addition to semaglutide.

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Compounding Compounding Pharmacies FDA Adverse Reactions 52

The Checkup by Singlecare

NOVEMBER 23, 2022

Food and Drug Administration (FDA) approved the first drug to delay the onset of Type 1 diabetes. Tzield received priority review from the FDA, a status given to drugs with the potential for “significant improvement” in the treatment, diagnosis, or prevention of a serious condition. 17, the U.S.

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STAT

JANUARY 31, 2024

Ideally, he said, the FDA should be able to both stay on top of safety concerns and avoid unnecessarily restricting access to drugs. I think there are definitely situations for many drugs where you can say, no, we’re not really at the right balance, and the FDA should be taking a more aggressive stance in promoting patient safety.

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Adverse Reactions FDA Labelling Hospitals 121