STAT

JULY 26, 2023

recently recalled a slew of injectable medicines used by hospitals over concerns about possible side effects and a newly released regulatory report underscores the extent of the problem. One of the largest compound pharmacy operations in the U.S. facility run by Central Admixture Pharmacy Services.

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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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Drug Topics

JUNE 18, 2025

The Mount Sinai Hospital. Sign up today for our free Drug Topics newsletter. REFERENCES 1. Gut microbiome composition and food insecurity linked to risk of cognitive impairment in adults. News release. June 18, 2025. Accessed June 18, 2025. Eggers S, Hoggarth ZE, Nagdeo K, et al.

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Communication Specialty Pharmacies Compounding Independent Pharmacies 377

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 141

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

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

Pharmaceutical Technology

JUNE 25, 2025

The US Food and Drug Administration (FDA) has approved Sanofi and Regeneron’s Dupixent (dupilumab) as a treatment option for adults with bullous pemphigoid (BP), a condition that predominantly affects the elderly. In February 2025, the FDA accepted Dupixent’s supplemental biologics licence application (sBLA) for priority review.

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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 119

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

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 142

pharmaphorum

AUGUST 21, 2020

It’s mission accomplished for Novartis after the FDA approved ofatumumab for multiple sclerosis, completing a project where the former cancer drug has been repurposed. The FDA approved ofatumumab under the brand name Kesimpta for people living with relapsing forms of multiple sclerosis.

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Pharmacy Times

JUNE 20, 2025

Furthermore, an investigation conducted by Norwalk et al found significant differences between Black and non-Black populations in pneumococcal mortality and length of hospital stay. Racial disparities in adult pneumococcal vaccination indications and pneumococcal hospitalizations in the US. J Natl Med Assoc. 2019;111(5):540-545.

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Vaccines Compounding Pharmacies Immunization Hospitals 73

pharmaphorum

DECEMBER 9, 2020

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading. The post FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel appeared first on.

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Pharmaceutical Technology

JUNE 10, 2025

MSD has received US Food and Drug Administration (FDA) approval for Enflonsia (clesrovimab-cfor) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants. Can pharma tariffs “Make America Manufacture Again”? Credit: MargJohnsonVA/Shutterstock.

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FDA Communication Research Laboratories Hospitals 52

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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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 115

Pharmaceutical Technology

JUNE 9, 2025

YolTech Therapeutics has received the US Food and Drug Administration (FDA) approval for its investigational new drug (IND) application for YOLT-101 to treat heterozygous familial hypercholesterolemia (HeFH). Credit: aipicte/Shutterstock. Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

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FDA Communication Hospitals Packaging 52

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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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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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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Pharmaceutical Technology

JUNE 18, 2025

Tisento Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for its investigational oral medicine, zagociguat, for mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes (MELAS), a rare mitochondrial disease. Credit: Volha_R/Shutterstock.

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FDA Communication Hospitals Packaging 52

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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pharmaphorum

OCTOBER 25, 2021

Hard on the heels of some impressive clinical trial results, Luminopia has won FDA approval for its digital therapeutic (DTx) for amblyopia or lazy eye in children that is based on watching TV shows. The post Luminopia scores FDA approval for TV-based amblyopia therapy appeared first on. Photo by Jessica Lewis on Unsplash.

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Pharmacy Times

JUNE 29, 2022

The approval eliminates the need for traditional nitric oxide tanks in the hospital setting.

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Hospitals FDA 123

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

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 82

Fierce Healthcare

AUGUST 7, 2024

Ohio-based University Hospitals Health System (UH) has teamed up with healthcare AI company Aidoc to catch conditions like pulmonary embolism, coronary artery calcification and intracrani | Aidoc's AI-based image analysis technology will be deployed in University Hospitals.

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Hospitals FDA 57

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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pharmaphorum

JULY 6, 2022

The FDA has granted a priority review to Roche’s T-cell engager Lunsumio as a treatment for follicular lymphoma (FL), setting up a decision on the drug by 29 December. The post FDA to decide on Roche’s lymphoma drug Lunsumio before year-end appeared first on.

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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 142

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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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 128

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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Pharmafile

FEBRUARY 29, 2024

Spero Therapeutics has announced that it has gained US Food and Drug Administration (FDA) clearance for the investigational new drug (IND) application to assess SPR206 in a phase 2 clinical study.

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STAT

MAY 15, 2023

In the early days of the Covid pandemic, gravely ill patients began to fill America’s hospitals. In a 2021 APC survey, more than 80 pharmacies nationwide reported they had provided compounded versions of those essential drugs to hospitals under the temporary guidance.

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Compounding Pharmacies Compounding Hospitals FDA 98

STAT

MAY 4, 2023

The Pfizer vaccine has also been tested to protect infants in their first six months of life — the age group at highest risk of being hospitalized with RSV — and is expected to gain FDA approval for that population later this year. Continue to STAT+ to read the full story…

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STAT

JULY 18, 2023

WASHINGTON — Medicare has a new proposal to pay hospitals more to stockpile essential drugs — an idea that comes as doctors report running low on critical chemotherapies and other drugs. But Medicare has its own new idea: paying hospitals to create a “buffer stock” of 86 medicines that HHS deems critical.

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