Drug Topics

MAY 24, 2023

The antibiotic, marketed as Xacduro, is indicated for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii.

FDA 187

FDA Hospitals 187

Fierce Pharma

OCTOBER 11, 2023

After a recent FDA approval and CDC recommendation, Pfizer's Abyrsvo is the first maternal vaccine to protect babies from respiratory syncytial virus (RSV). | The vaccine, if used widely, could generate savings of up to $800 million and cut infant hospitalizations in half, according to a Pfizer study set to be presented at IDWeek 2023.

Hospitals 67

Hospitals Vaccines FDA 67

Drug Topics

FEBRUARY 10, 2023

The FDA has updated its compounding guidelines for licensed pharmacies, hospitals, and health systems.

FDA 98

FDA Compounding Hospitals 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.

Hospitals 145

Hospitals FDA 145

The FDA Law Blog

MARCH 29, 2024

Richardson — While Covid is in the rear view for most of us, FDA has had a tough time shaking off the effects of the pandemic on its inspection output. In March 2020 , FDA temporarily postponed all foreign and domestic and routine surveillance facility inspections. Inspections went down—way down—during the pandemic.

FDA 59

FDA Hospitals 59

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.

FDA 98

FDA Hospitals 98

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.

FDA 145

FDA Hospitals 145

Drug Topics

NOVEMBER 30, 2023

Levetiracetam and clobazam can cause Drug Reaction with Eosinophilia and Systemic Symptoms, which can start as a rash but progress quickly, potentially resulting in injury to internal organs, hospitalization, and death.

FDA 98

FDA Hospitals 98

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.

Hospitals 107

Hospitals FDA 107

The FDA Law Blog

MARCH 31, 2024

Gibbs — On March 21, 2024, the House Energy and Commerce held a subcommittee hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” FDA, which was not invited to participate, would surely have concurred. The FDA proposed rule elicited some strong criticism.

FDA 64

FDA Hospitals 64

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. 

FDA 100

FDA Hospitals 100

pharmaphorum

SEPTEMBER 29, 2022

A digital patient monitoring tool developed by UK company CyberLiver has been given a breakthrough designation by the FDA for out-of-hospital management of patients with cirrhosis at risk of complications. The post Digital tool cuts hospital readmissions in cirrhosis patients appeared first on.

Hospitals 52

Hospitals Communication FDA 52

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.

FDA 97

FDA Specialty Pharmacies Labelling Hospitals 97

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.

Vaccines 98

Vaccines FDA Hospitals Immunization 98

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.

FDA 103

FDA Hospitals 103

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.

FDA 117

FDA Hospitals 117

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).

FDA 98

FDA Labelling Hospitals 98

PharmExec

JULY 25, 2023

FDA stresses facility only responsible for 8% of total US hospital consumption for sterile injectable drug market, as well as the need for a reliable drug supply chain.

FDA 52

FDA Hospitals 52

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.

FDA 324

FDA Hospitals Communication 324

pharmaphorum

FEBRUARY 3, 2021

France’s SurgAR has joined with imaging data firm Medexprim to form a three-year partnership with a major hospital in France, to develop augmented reality (AR) software dedicated to laporoscopic surgery. The University Hospital Centre of Clermont-Ferrand has been ranked in the top 20 French hospitals for nine years and has 7,000 staff.

Hospitals 69

Hospitals FDA 69

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.

FDA 144

FDA Hospitals 144

Pharmacy Times

MAY 9, 2023

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

Labelling 123

Labelling Hospitals FDA 123

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…

FDA 131

FDA Hospitals 131

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.

Hospitals 123

Hospitals FDA 123

The People's Pharmacy

MAY 8, 2023

Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.

FDA 72

FDA Pharmaceutical Companies Pharmaceutical Companies Medical Schools 72

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.

Vaccines 98

Vaccines Hospitals FDA 98

The FDA Law Blog

SEPTEMBER 28, 2022

Valley Hospital, Inc. 25, 2022), [link] , considered whether a provider’s use of a medical device that is the subject of an FDA safety communication constitutes per se evidence of wanton disregard, which would warrant punitive damages. Depending on the wording of other FDA notices, that may not always be the case. Case Summary.

Communication 59

Communication FDA Hospitals 59

pharmaphorum

SEPTEMBER 30, 2022

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. The post Relief for Amylyx as FDA clears controversial ALS drug Relyvrio appeared first on.

FDA 98

FDA Specialty Pharmacies Labelling Hospitals 98

Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. The FDA’s action plan. Thus, FDA funding could be what is needed on this front, says Cudkowicz.

FDA 98

FDA Hospitals 98

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.

Adverse Reactions 111

Adverse Reactions FDA Labelling Hospitals 111

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.

FDA 98

FDA Immunization Hospitals 98

Digital Pharmacist

OCTOBER 24, 2022

The FDA protects public health by ensuring the efficacy and safety of human and veterinary drugs, including biological products and medical devices. It is critical for the FDA to continue to develop new advances in therapies to aid our communities in order to achieve better lives through better health. Date of Approval: 9/30/2022.

FDA 75

FDA Adverse Reactions Pharmaceutical Companies Pharmaceutical Companies 75

pharmaphorum

APRIL 14, 2021

That is at the top end of the range of reductions achieved with monoclonal antibodies targeting SARS-CoV-2 that have been granted EUAs by the FDA, it says. Based on the findings, Romark says it is working with the FDA to try to get an EUA for NT-300. Severe disease was seen in 0.5% of the NT-300 group (one patient), compared to 3.5%

FDA 104

FDA Hospitals Vaccines 104

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.

Vaccines 109

Vaccines FDA Adverse Reactions Documentation 109

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.

Hospitals 98

Hospitals Chemotherapy FDA 98

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.

Compounding Pharmacies 98

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…

Vaccines 98

Vaccines FDA Hospitals 98