Labelling - Pharmacy Technician Pulse

Can Patient-Centered Prescription Labels Increase Medication Adherence?

Drug Topics

FEBRUARY 9, 2023

Researchers evaluated how changes in USP labeling standards have affected adherence across multiple classes of drugs.

Labelling

Gluten in Medications: Why Labeling Matters for Patients With Celiac Disease

Drug Topics

OCTOBER 3, 2023

Despite pleas from celiac disease advocates, the FDA still does not require drug manufacturers to note on the label whether a medication contains gluten.

Labelling

Labelling FDA

FDA Adds Delayed Gastric Emptying as Adverse Event on Semaglutide Label

Pharmacy Times

NOVEMBER 14, 2024

The label includes postmarking reports showing rare instances of pulmonary aspiration for patients undergoing procedures that require general anesthesia or deep sedation.

Labelling

Labelling FDA

STAT+: Obesity drug Wegovy gets FDA approval to add cardiovascular benefits on its label

STAT

MARCH 8, 2024

regulators approved a label expansion for Novo Nordisk’s obesity drug Wegovy to tout its benefits for the heart, a move that could boost demand and insurance coverage for the already highly popular treatment. Novo said it has also filed for a label expansion in Europe and a decision is expected this year.

Labelling

Labelling Insurance Coverage Insurance FDA

Deadline looms for post-Brexit label changes for UK meds

pharmaphorum

DECEMBER 3, 2024

The MHRA has reminded pharma companies that from 1st January all medicines sold in the UK will have to comply with new labelling requirements

Labelling

Off-label treatment for alcohol use disorder is linked to slower liver decline, study suggests

STAT

MAY 22, 2024

But a different medication, one frequently used off-label for the condition, could provide greater benefit to patients with alcohol-associated liver disease, a new study suggests. WASHINGTON — There are three FDA-approved drugs for treating alcohol use disorder.

Labelling

Labelling FDA

HLTH24: Here’s a first look at a draft 'nutrition label' for health AI

Fierce Healthcare

OCTOBER 20, 2024

The Coalition for Health AI released a draft of their AI model card, or “nutrition label” for AI, filled out with information from AI imaging company Aidoc. LAS VEGAS—The Coalition for Health AI unveiled the first applied model card, completed by AI imaging company Aidoc. |

Labelling

PDURS explained: The FDA’s new framework for adding software to drug labels

pharmaphorum

MAY 20, 2024

In this fireside chat webinar, experts break down the FDA's new PDURS framework for adding software to drug labels. Learn how it impacts pharma and what you need to know. Join us on Tuesday 9th July @ 07:00am PDT / 10:00am EDT / 15:00pm BST / 16:00pm CEST.

Labelling

Labelling FDA

Novo's obesity superstar Wegovy wins FDA nod to cut cardio risks in key label expansion

Fierce Pharma

MARCH 8, 2024

Novo Nordisk’s fast-growing weight loss med Wegovy just added a new cardiovascular FDA approval to its label, likely enabling the med's superstar status to reach new levels. |

Labelling

Labelling FDA

Sarepta bags key expansion to DMD gene therapy label in US

pharmaphorum

JUNE 20, 2024

Sarepta gets best-case approval from the FDA for an expansion to the label for its Duchenne muscular dystrophy gene therapy Elevidys.

Labelling

Labelling FDA

STAT+: Lawmakers want FTC to probe big PBMs over private-label biosimilar deals

STAT

OCTOBER 2, 2024

In reality, the arrangements actually resemble private-label distribution, but the lawmakers worry these agreements could cause consumers to pay higher prices. These new business units have since used these deals as springboards to market the medications to health plans.

Labelling

Labelling Pharmaceutical Companies Pharmaceutical Companies Insurance

Sarepta scores 'transformational' FDA label expansion for Duchenne gene therapy Elevidys

Fierce Pharma

JUNE 20, 2024

The FDA has expanded the label for Sarepta's Elevidys to all Duchenne muscular dystrophy patients ages 4 and older. There’s no slowing the momentum of Sarepta’s groundbreaking Duchenne muscular dystrophy (DMD) gene therapy Elevidys—not even the failure of a confirmatory trial. |

Labelling

Labelling FDA

STAT+: New Wegovy analysis could boost Novo Nordisk’s bid to expand drug’s label in heart failure

STAT

AUGUST 30, 2024

Novo Nordisk’s obesity drug Wegovy cut the risk of severe complications in patients with a common form of heart failure, according to a new analysis that could boost the company’s efforts to expand the label for the blockbuster treatment. of those who received placebo.

Labelling

Labelling Hospitals

FDA blesses atopic dermatitis label expansions for Organon's Vtama, Galderma's Nemluvio

Fierce Pharma

DECEMBER 16, 2024

Vtamas label expansion came just three days after the FDA gave a thumbs up to Galdermas Nemluvio, which was previously endorsed by the FDA for prurigo nodularis. . | The FDA has blessed two previously approved medicinesone a cream and the other an injectionto treat atopic dermatitis (AD).

Labelling

Labelling FDA

FDA Approves Updated Label for Altuviiio for Effective Bleed Protection in Children Younger than 12 Years

Drug Topics

MAY 13, 2024

Altuviiio was first granted approval by the FDA in February 2023.

Labelling

Labelling FDA

Trio of Indian drugmakers issue recalls tied to impurity, labeling issues

Fierce Pharma

DECEMBER 18, 2024

Indian drugmakers Aurobindo, Glenmark and Zydus have issued separate sweeping drug recalls over issues pertaining to impurities and labeling. Indian drugmakers Aurobindo, Glenmark and Zydus have issued separate sweeping drug recalls over issues pertaining to impurities and labeling.

Labelling

Labelling FDA

Off-Label Semaglutide Linked to Deaths, Hospitalizations Calling for Compounding Regulation

Pharmacy Times

NOVEMBER 8, 2024

Off-label semaglutide has been linked to serious adverse effects, calling for increased regulation around compounding.

Compounding

Compounding Labelling Hospitals

Pharmacy Education Must Keep Pace With Changing Health Care Landscape | ACCP 2024

Drug Topics

OCTOBER 16, 2024

Posters presented at ACCP 2024 revealed gaps in pharmacy students’ understanding of off-label drug applications and identified strengths and weaknesses among pharmacy graduates.

Labelling

FDA Requires Abrysvo, Arexvy RSV Vaccine Labels to Include Guillain-Barré Warning

Drug Topics

JANUARY 8, 2025

Patients who receive either Pfizer or GSKs respiratory syncytial virus vaccine may be at increased risk of Guillain-Barr syndrome.

Vaccines

Vaccines Labelling FDA

FDA Approves Updated Label for Bempedoic Acid, Ezetimibe Tablets

Pharmacy Times

DECEMBER 14, 2023

The update also removed the maximally tolerated qualifier for statin use and the statement that said morbidity and mortality was not yet determined.

Labelling

Labelling FDA

FDA Expands Label for Bempedoic Acid to Reduce Cardiovascular Risk, With or Without Statins

Pharmacy Times

MARCH 22, 2024

Bempedoic acid (Nexletol; Esperion) and bempedoic acid and ezetimibe (Nexlizet; Esperion) are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.

Labelling

Labelling FDA

Floreo nabs FDA breakthrough label for its VR software

Fierce Healthcare

DECEMBER 11, 2023

Floreo, maker of virtaul reality (VR) behavioral therapy content, has received the Food and Drug Administration’s breakthrough device designation. | Floreo says it seeks full market authorization to further recognize its effectiveness and to open up reimbursement pathways for its tech to reach more families.

Labelling

Labelling FDA

15 Antibiotic Myths To Beware

IDStewardship

OCTOBER 27, 2022

Myth 9: Penicillin allergy labels are not a big deal. Approximately 10% of the US adult population has a penicillin allergy label and only about 10% of those labels represent true allergies. Inappropriate penicillin allergy labels are a scourge on our society and force us to use second- or third-line treatments.

Labelling

Labelling FDA

What’s in a drink? U.S. regulators consider new alcohol label, but health advocates want even more

STAT

AUGUST 12, 2024

If you twirl a bottle of alcohol and squint, you might see a text box with a warning. Usually in black and white, with letters two to three millimeters high, it reads: GOVERNMENT WARNING: (1) According to the Surgeon General, women should not drink alcoholic beverages during pregnancy because of the risk of birth defects. (2)

Labelling

SpartanNash unveils Finest Reserve premium private label brand

Drug Store News

FEBRUARY 23, 2024

The collection is currently a curated offering of artisan-crafted frozen pizzas, upscale pastas, sauces, dressings, premium and more.

Labelling

How Do White Label Products Work for Pharmacies?

PioneerRx

SEPTEMBER 17, 2024

As you well know, there are countless ways to make more money for your pharmacy. From leveraging your pharmacy technology to expanding your clinical services.

Labelling

FDA Approves Label Update for Biktarvy as Treatment of HIV in Pregnant Adults

Pharmacy Times

APRIL 26, 2024

The approval is based on data from Study 5310, evaluating the pharmacokinetics, safety, and efficacy of Biktarvy (Gilead Sciences Inc) in pregnant individuals.

Labelling

Labelling FDA

Lantidra Cell Therapy for Type 1 Diabetes Approved by FDA

Drug Topics

JUNE 29, 2023

The approval was based on safety and efficacy data from 30 participants in 2 open-label, single-arm studies that received 1 to 3 infusions of donislecel.

Labelling

Labelling FDA

J&J bids to add smouldering myeloma to Darzalex label

pharmaphorum

NOVEMBER 10, 2024

Johnson & Johnson looks on course to make Darzalex the first approved drug therapy for smouldering multiple myeloma, after a phase 3 win

Labelling

Latin labelling on cosmetics is a risk to food allergy sufferers, says MP

The Guardian - Pharmaceutical Industry

OCTOBER 19, 2024

Becky Gittins calls for cosmetic firms to list ingredients in English, saying current labelling is ‘absolutely bonkers’ Cosmetic companies need to stop forcing people with food allergies to learn Latin to safeguard their health and display warnings written in plain English, according to an MP with a history of severe allergic reactions who is demanding (..)

Labelling

EPINEPHrine Nasal Solution, USP Recalled for Lack of Approval, Misbranding

Pharmacy Times

DECEMBER 23, 2024

The nasal spray label resembles that of the FDA-approved epinephrine injection, leading to potential dosing errors.

Labelling

Labelling FDA

Online Pharmacies Are Illegally Selling GLP-1s Without Prescriptions

Drug Topics

AUGUST 5, 2024

A study found that test products purchased from illegal online pharmacy operations had lower purity levels and significantly more semaglutide content than what was advertised on the label.

Labelling

FDA expands Novartis’ Kisqali label to include early breast cancer patients

Pharmaceutical Technology

SEPTEMBER 18, 2024

Kisqali generated $2bn in sales last year, with broader approvals forecasting sales of over $8bn by 2030, per GlobalData analysis.

Labelling

Labelling FDA

Noom to offer compounded GLP-1 drug to rival pricey branded weight loss meds

Fierce Healthcare

SEPTEMBER 17, 2024

Noom is the latest digital health company to jump into the off-label weight loss drug market to make medications more accessible to consumers. Noom is the latest digital health company to jump into the off-label weight loss drug market to make medications more accessible to consumers.

Compounding

Compounding Labelling

FDA Approves Updated Label for Altuviiio to include Full Data on Pediatric Patients With Hemophilia A

Pharmacy Times

MAY 13, 2024

Antihemophilic factor (recombinant) Fc-VWF-XTEN fusion protein-ehtl was initally approved in February 2023 for adults and children with hemophilia A for prophylaxis and on-demand treatment to control bleeding.

Labelling

Labelling FDA

Newest Indication for Bempedoic Acid Expands Patient Population

Pharmacy Times

APRIL 9, 2024

In March 2024, the label for bempedoic acid was expanded to reduce cardiovascular risk and expand the low-density lipoprotein-C (LDL-C) lowering in both primary and secondary prevention patients.

Labelling

J&J’s Darzalex combination gains expanded label for multiple myeloma in Europe

Pharmaceutical Technology

OCTOBER 23, 2024

Darzalex will now be available to patients with newly diagnosed multiple myeloma eligible for autologous stem cell transplant.

Labelling

FDA Accepts Supplemental New Drug Application for Tapinarof Cream, 1%, in Atopic Dermatitis

Pharmacy Times

APRIL 29, 2024

The acceptance is based on positive data from the phase 3 ADORING 1 and ADORING 2 pivotal trials, as well as interim results from the phase 3 ADORING 3 open-label, long-term extension trial.

Labelling

Labelling FDA

Develop Strategies for Managing Medications During Sick Days

Pharmacy Times

MAY 10, 2024

Strategies for intervention design focused on opportunities for both patients and providers by way of medication labeling, specific prescription instructions, prescribing prompts, and educational services.

Medication Labelling

Medication Labelling Labelling

Educate Patients About Cough and Cold Product Ingredients

Pharmacy Times

JUNE 19, 2024

Read the Drug Facts Label to Learn More About OTC Medications.

Labelling

Have Children Truly Ever Been ‘Therapeutic Orphans?’

Pharmacy Times

JUNE 16, 2023

Imposing the FDA on-label/off-label framework on administratively defined "children" resulted in a regulatory demand for pediatric studies that had no basis in clinical medicine, with the exception of the small group of preterm newborns.

Labelling

Labelling FDA

GSK5764227 Receives Breakthrough Therapy Designation to Treat Extensive-Stage Small–Cell Lung Cancer

Pharmacy Times

AUGUST 20, 2024

The breakthrough therapy designation was granted based on ongoing data from the ARTEMIS-001 phase 1 open-label, multi-center trial.

Labelling

What’s the evidence for the Surgeon General’s proposed social media warning?

STAT

JUNE 17, 2024

United States Surgeon General Vivek Murthy wants to add a warning label on social media.

Labelling

Fighting the Flu With Supplements: The Pharmacist’s Patient Counseling Guide

Pharmacy Times

JULY 19, 2024

Confusing product labeling and conflicting data can create challenges for patients.

Labelling

Can Patient-Centered Prescription Labels Increase Medication Adherence?

Gluten in Medications: Why Labeling Matters for Patients With Celiac Disease

Trending Sources

FDA Adds Delayed Gastric Emptying as Adverse Event on Semaglutide Label

STAT+: Obesity drug Wegovy gets FDA approval to add cardiovascular benefits on its label

Deadline looms for post-Brexit label changes for UK meds

Off-label treatment for alcohol use disorder is linked to slower liver decline, study suggests

HLTH24: Here’s a first look at a draft 'nutrition label' for health AI

PDURS explained: The FDA’s new framework for adding software to drug labels

Novo's obesity superstar Wegovy wins FDA nod to cut cardio risks in key label expansion

Sarepta bags key expansion to DMD gene therapy label in US

STAT+: Lawmakers want FTC to probe big PBMs over private-label biosimilar deals

Sarepta scores 'transformational' FDA label expansion for Duchenne gene therapy Elevidys

STAT+: New Wegovy analysis could boost Novo Nordisk’s bid to expand drug’s label in heart failure

FDA blesses atopic dermatitis label expansions for Organon's Vtama, Galderma's Nemluvio

FDA Approves Updated Label for Altuviiio for Effective Bleed Protection in Children Younger than 12 Years

Trio of Indian drugmakers issue recalls tied to impurity, labeling issues

Off-Label Semaglutide Linked to Deaths, Hospitalizations Calling for Compounding Regulation

Pharmacy Education Must Keep Pace With Changing Health Care Landscape | ACCP 2024

FDA Requires Abrysvo, Arexvy RSV Vaccine Labels to Include Guillain-Barré Warning

FDA Approves Updated Label for Bempedoic Acid, Ezetimibe Tablets

FDA Expands Label for Bempedoic Acid to Reduce Cardiovascular Risk, With or Without Statins

Floreo nabs FDA breakthrough label for its VR software

15 Antibiotic Myths To Beware

What’s in a drink? U.S. regulators consider new alcohol label, but health advocates want even more

SpartanNash unveils Finest Reserve premium private label brand

How Do White Label Products Work for Pharmacies?

FDA Approves Label Update for Biktarvy as Treatment of HIV in Pregnant Adults

Lantidra Cell Therapy for Type 1 Diabetes Approved by FDA

J&J bids to add smouldering myeloma to Darzalex label

Latin labelling on cosmetics is a risk to food allergy sufferers, says MP

EPINEPHrine Nasal Solution, USP Recalled for Lack of Approval, Misbranding

Online Pharmacies Are Illegally Selling GLP-1s Without Prescriptions

FDA expands Novartis’ Kisqali label to include early breast cancer patients

Noom to offer compounded GLP-1 drug to rival pricey branded weight loss meds

FDA Approves Updated Label for Altuviiio to include Full Data on Pediatric Patients With Hemophilia A

Newest Indication for Bempedoic Acid Expands Patient Population

J&J’s Darzalex combination gains expanded label for multiple myeloma in Europe

FDA Accepts Supplemental New Drug Application for Tapinarof Cream, 1%, in Atopic Dermatitis

Develop Strategies for Managing Medications During Sick Days

Educate Patients About Cough and Cold Product Ingredients

Have Children Truly Ever Been ‘Therapeutic Orphans?’

GSK5764227 Receives Breakthrough Therapy Designation to Treat Extensive-Stage Small–Cell Lung Cancer

What’s the evidence for the Surgeon General’s proposed social media warning?

Fighting the Flu With Supplements: The Pharmacist’s Patient Counseling Guide

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