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.
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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.
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High Prevalence of Off-Label Prescribing in Pediatric Palliative Care
Drug Topics
MARCH 4, 2025
Researchers explored the differences in off-label prescribing between pharmacists and physicians among a cohort of patients in pediatric palliative care.
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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.
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FDA Approves Updated Buprenorphine Label For Rapid Initiation Treatment
Drug Topics
FEBRUARY 24, 2025
The updated label also includes alternative injection sites, such as the abdomen, thigh, buttock, or back of the upper arm.
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Leqvio Gets Label Update For Earlier Use in Patients with Heart Disease
Drug Topics
JULY 12, 2023
Recent safety data also allowed four adverse events to be removed from the label.
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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.
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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.
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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.
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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.
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Male Patients With Diabetes, Obesity Have Poorer Prognosis of Thyroid Cancer
Drug Topics
FEBRUARY 12, 2025
Recently, there has been concern around glucagon-like peptide-1 receptor agonists and increase the risk of thyroid cancer, with liraglutide having a black box warning label for the disease.
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FDA Roundup: Updated Label for Altuviiio, CRL Given to Heplisav-B
Drug Topics
MAY 17, 2024
Check out important updates from the FDA for the week of May 13.
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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.
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FDA Updates Viloxazine Label for ADHD
Pharmacy Times
JANUARY 27, 2025
Based on the updated label, new pharmacodynamic data have been added for a better understanding of the drug for individuals with attention-deficit/hyperactivity disorder (ADHD).
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Q&A: How gluten-free processed foods put people with celiac disease at risk
STAT
FEBRUARY 3, 2025
” The underlying issues range from inaccurate food labels to a culture that often treats gluten-free eating as a lifestyle choice rather than a medical requirement — giving food manufacturers and restaurants more leeway to play fast and loose with the term. (Indeed, All three grains contain gluten.
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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
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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.
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FDA Approves Label Expansions, New Indication for Bempedoic Acid Tablets for CV Prevention
Drug Topics
MARCH 22, 2024
The approval represents the first non-statin treatment indicated to lower low-density lipoprotein for primary prevention patients.
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STAT+: Drug may make chemotherapies less effective in cancer patients with obesity — but many doctors are in the dark
STAT
OCTOBER 28, 2024
The information, however, is not in the label because the drug — originally manufactured by Merck — was never fully tested in this population. As the original brand-name manufacturer, however, Merck continues to have legal responsibility for the labeling, which means that all available versions lack the details.
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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.
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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. |
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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.
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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.
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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.
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FDA Updates Veozah Label With Boxed Warning for Rare But Serious Liver Injury
Drug Topics
DECEMBER 18, 2024
The patients symptoms gradually resolved after discontinuing fezolinetant therapy.
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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. |
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Paxlovid EUA Revision Narrows Emergency Use to Pediatric Patients
Drug Topics
JANUARY 29, 2024
The FDA states the revision to the emergency use authorization (EUA) is the next phase in the transition from the use of EUA-labeled nirmatrelvir and ritonavir to the use of NDA-labeled nirmatrelvir and ritonavir.
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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. |
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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.
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STAT+: ‘Skinny labels’ on generic medicines saved Medicare $15 billion over a recent six-year period
STAT
APRIL 30, 2024
The provision is known as skinny labeling, which refers to a move by a company that seeks regulatory approval to market a generic or biosimilar medicine for a specific use, but not for other patented uses for which the brand-name drug is prescribed. In short, this is a so-called carve-out.
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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.
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Ibuprofen Injection Approved by FDA to Treat Fever, Pain in Infants
Drug Topics
JUNE 16, 2023
The expanded labeling allows for an intravenously delivered formulation of ibuprofen (Caldolor) in infants aged 3 to 6 months.
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Methadone at home? Emerging tech provides new tool in the fight against opioid addiction
PharmaVoice
SEPTEMBER 15, 2022
Sonara Health’s inexpensive, specially engineered label and web app allow for at-home, digitally supervised dosing of high-cost or high-risks drugs.
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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).
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Toxicity Management Crucial When Combining Novel Agents
Drug Topics
APRIL 5, 2023
Off-label drug combinations are increasingly being used in cancer treatments, but there is the potential for overlapping or additive toxicities, explained a speaker at the 2023 HOPA Annual Conference.
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FDA Proposes Front-of-Package Nutrition Label for Most Packaged Foods
Pharmacy Times
JANUARY 17, 2025
If finalized, the requirement would include readily available nutrition information, including saturated fat, sodium, and added sugar content.
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FDA Issues New Labeling Changes Clarifying Safety of Testosterone Products Following Clinical Trials
Pharmacy Times
MARCH 4, 2025
The FDA is issuing new changes to labels on testosterone products, clarifying that there are no increases in major cardiac events among men with hypogonadism but noting an increase in blood pressure with the use of such products.
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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.
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FDA OKs Label Changes for Buprenorphine Injections, Reducing Time to Treatment in Opioid Use Disorder
Pharmacy Times
FEBRUARY 25, 2025
The label changes to buprenorphine extended-release injections can increase convenience and adherence for patients with moderate to severe opioid use disorder.
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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.
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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.
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FDA issues warnings to GLP-1 compounders
The Checkup by Singlecare
DECEMBER 19, 2024
The company was using a false or misleading label claiming that one of its products has been approved by the FDA. The FDA also sent a warning letter to the CEO of Veronvy, a company that has been selling unapproved and misbranded oral GLP-1s on its website.
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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.
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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.
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