Drug Topics

MAY 17, 2024

Check out important updates from the FDA for the week of May 13.

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Labelling FDA 247

Fierce Pharma

OCTOBER 25, 2024

Despite recent concerns from the FDA about potential off-label use and antimicrobial resistance, Dublin-based Iterum Therapeutics has scored a green light for its oral antibiotic sulopenem. The FDA nod marks the second approval this year for a uUTI medicine after two decades of stagnation in the field.

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FDA Labelling 122

STAT

JANUARY 15, 2025

A new government proposal to display nutritional labels on the front of food packaging is aimed at helping Americans make more informed choices about what they eat. The FDA says the ratings could incentivize manufacturers to reduce levels of those three nutrients, although that’s not the agency’s goal in proposing the change.

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Labelling Packaging FDA 131

The FDA Law Blog

JANUARY 9, 2025

Farquhar This is the first in a series of blog posts on tips for successfully handling an FDA inspection. Using publicly available examples, these lessons will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection. FD&C Act 501(j).

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Drug Topics

APRIL 8, 2025

In part 3 of our interview with Jenny Markell, BA, she discussed drug advertising trends among Alzheimers disease drugs and how FDA suggestions are not necessarily followed.

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Labelling FDA 247

Drug Topics

JULY 10, 2025

Private-Label Partnerships can Streamline Operations and Enhance the Customer Experience Offering a broad selection of private-label OTC products can help your pharmacy stay competitive and support your customers’ evolving needs. Private-label brands allow you to deliver the same quality as larger name brands, often at a lower cost.

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Pharmaceutical Technology

JUNE 26, 2025

The US FDA has granted approval for a label update to Eli Lilly and Company's Amyvid (florbetapir F 18 injection) for use intravenously.

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Labelling FDA 52

pharmaphorum

MAY 22, 2025

The FDA has instructed Pfizer and Moderna to add stronger warnings to the labels of their COVID-19 vaccines about the risk of cardiotoxicity

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Vaccines FDA Labelling 136

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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Labelling FDA 247

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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Labelling FDA 122

Fierce Pharma

DECEMBER 16, 2024

The FDA has blessed two previously approved medicinesone a cream and the other an injectionto treat atopic dermatitis (AD). | The FDA has blessed two previously approved medicinesone a cream and the other an injectionto treat atopic dermatitis (AD).

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Labelling FDA 118

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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Labelling FDA 139

Pharmacy Times

JUNE 26, 2025

Amyvid is used for brain imaging to estimate amyloid plaque density in patients with cognitive impairment undergoing evaluation for Alzheimer disease.

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Labelling FDA 73

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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Labelling FDA 136

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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Labelling FDA 126

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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Labelling FDA 247

Drug Topics

DECEMBER 18, 2024

The patients symptoms gradually resolved after discontinuing fezolinetant therapy.

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Labelling FDA 190

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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Labelling FDA 247

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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Grocery Stores Labelling FDA 127

STAT

MAY 22, 2024

WASHINGTON — There are three FDA-approved drugs for treating alcohol use disorder. 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. 

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Labelling FDA 139

STAT

DECEMBER 22, 2023

The Food and Drug Administration issued a change to the warning label for Legend Biotech and Janssen’s myeloma CAR-T, Carvykti or cilta-cel, adding that some secondary blood cancers have occurred following treatment for multiple myeloma with the cell therapy. 

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STAT

JUNE 3, 2025

 In an internal message, FDA Commissioner Mark Makary told employees they could use the AI tool, called Elsa, to “expedite clinical protocol review and reduce the overall time to complete scientific review.”

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FDA Labelling 99

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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Labelling FDA 89

Pharmaceutical Technology

JUNE 25, 2025

The US Food and Drug Administration (FDA) has expanded the indications of an imaging agent developed by GE HealthCare, which will likely put it at the forefront of the Alzheimer’s diagnostics arena. Last month, the FDA approved the Lumipulse G test , the first blood test to help diagnose the disease.

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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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Labelling FDA 119

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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Labelling FDA 111

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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Packaging Labelling FDA 144

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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Labelling FDA 98

pharmaphorum

MARCH 11, 2024

Novo Nordisk’s Wegovy has been given a first-in-class approval by the FDA to reduce the risk of serious cardiovascular conditions in people who are overweight or obese

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Labelling FDA 111

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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Labelling FDA 139

Fierce Pharma

NOVEMBER 17, 2023

The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi. | The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi.

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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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Labelling FDA 128

STAT

NOVEMBER 7, 2023

1 letter, the AGs noted that it had been a year since the FDA convened a public meeting of experts , who called for clearer labeling and more rigorous testing of the devices, and that no action had been taken. Read the rest…

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FDA Labelling 145

Fierce Pharma

SEPTEMBER 28, 2023

Fabre-Kramer Pharmaceuticals' major depressive disorder (MDD) drug gepirone has been rejected by the FDA not once, not twice, but three times since the turn of the millennium. Fabre-Kramer's Exxua suffered three prior FDA rejections before scoring an FDA approval for major depressive disorder last week.

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Adverse Reactions FDA Labelling 134

Fierce Pharma

SEPTEMBER 26, 2024

The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered. | The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered.

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FDA Labelling 121

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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Labelling FDA 152

Fierce Pharma

DECEMBER 5, 2024

AstraZeneca has picked off another label expansion for cancer blockbuster Imfinzi as the FDA has blessed it for limited-stage small cell lung cancer.

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FDA Labelling 121