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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Labelling Chemotherapy FDA Patient Care 111

PharmExec

JANUARY 11, 2024

Best practices for defending against lawsuits based on pharmaceutical labeling, including avenues for early resolution of the case and, as necessary, strategies for developing the best evidence for defense.

Labelling 52

Labelling 52

Fierce Pharma

FEBRUARY 29, 2024

Despite a restricted FDA label, Sarepta Therapeutics has seen early commercial success with its Duchenne muscular dystrophy (DMD) gene therapy Elevidys. | The company is quickly moving through Elevidys' eligible patient population while awaiting the FDA's decision on a broader label.

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Labelling FDA 76

Fierce Pharma

NOVEMBER 2, 2023

Even before a potential label expansion, the gene therapy Elevidys has raked in around $69 million since its launch. But Sarepta plans to seek a label expansion for the DMD gene therapy anyway. Earlier this week, the company said that a pivotal trial on the medicine failed to reach its primary endpoint.

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Labelling 105

Hospital Pharmacy Europe

MARCH 26, 2024

It is likely to be safe for penicillin allergy labels (PALs) to be removed for most patients, a study from the University of Birmingham has found. Some 97% of participants labelled with PALs were shown to have no allergy. However, a large body of evidence suggests that 90-95% of PALs are inaccurate.

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Labelling Hospitals 52

Pharmaceutical Technology

MARCH 29, 2024

Its label was expanded in 2022 for use in patients 12 years and older. Vemlidy was first approved to treat adults with HBV in 2016.

Labelling 52

Labelling 52

Pharmaceutical Technology

OCTOBER 24, 2023

The FDA released a draft guidance giving firms recommendations on provider-directed communication for off-label drug use.

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Labelling FDA Communication 98

Fierce Pharma

JUNE 16, 2023

Merck’s cancer star Keytruda could be on its way to an updated label in HER2-positive stomach cancer after showing it can stave off tumor progression in a combination study.

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Labelling 126

pharmaphorum

AUGUST 25, 2023

CVS Health launches private label biosimilars unit Phil.Taylor Fri, 25/08/2023 - 08:07 Bookmark this

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Labelling 96

Pharmacy Times

JANUARY 19, 2024

As the body of data has grown, clinicians’ propensity to use selective serotonin reuptake inhibitors off-label has increased

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Labelling 65

pharmaphorum

AUGUST 2, 2023

Samsung seeks 'interchangeable' label for Humira biosimilar Phil.Taylor Wed, 02/08/2023 - 10:37 Bookmark this

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Labelling 98

Drug Store News

JULY 6, 2023

Know & Love will offer a wide range of affordable and clean-label products, including food, beverage and household items.

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Labelling 97

Pharmaceutical Technology

MARCH 12, 2024

Johnson & Johnson’s Tremfya is approved for plaque psoriasis and active psoriatic arthritis, with a label for ulcerative colitis now on the horizon.

Labelling 52

Labelling 52

pharmaphorum

NOVEMBER 17, 2023

AZ first to AKT finish line, but FDA clears narrow label Phil.Taylor Fri, 17/11/2023 - 09:46 Bookmark this

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Labelling FDA 103

Fierce Pharma

SEPTEMBER 15, 2023

With the potential for more than two dozen label expansions on the horizon, Bristol Myers Squibb bets its pipeline can help it withstand the pressure from the Inflation Reduction Act and a trio of | With the potential for more than two dozen label expansions on the horizon, Bristol Myers Squibb bets its pipeline can help it withstand the pressure from (..)

Labelling 101

Labelling 101

pharmaphorum

JUNE 28, 2023

AbbVie, Genmab eye label expansion for Epkinly Phil.Taylor Wed, 28/06/2023 - 13:04 Bookmark this

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Labelling 98

The FDA Law Blog

MARCH 5, 2024

Many individual states have pursued some type of legislation to restrict the use of traditional meat terminology for the labeling of APPs. Many states have proposed but failed to enact legislation regulating the labeling of APPs, in some cases due to concerns of potential legal challenges based on federal preemption claims.

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Labelling FDA 59

STAT

JUNE 20, 2023

Much of the Americas already has so-called front of package labels — small symbols printed on packaged foods that alert consumers when a food is high in certain unhealthy nutrients like sodium or saturated fat. Now, the Food and Drug Administration is embarking on a major study to test front of package labels here in the U.S.,

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Packaging Labelling Grocery Stores FDA 95

The FDA Law Blog

MAY 11, 2023

GSK skinny label case , the U.S. Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.”

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Labelling FDA Documentation Communication 72

Drug Store News

JULY 26, 2023

Dollar General is debuting more than 100 new items in its Clover Valley private label line in 2023.

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Labelling 98

Pharmaceutical Commerce

SEPTEMBER 19, 2023

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

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Labelling Documentation FDA 52

Fierce Pharma

SEPTEMBER 1, 2023

When it comes to heart failure medication, a labeling mix-up can have dire consequences. Marlex Pharmaceuticals of New Castle, Delaware, is recalling two lots of digoxin tablets at the 0.125-mg and 0.25-mg mg dose, and vice versa.

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Labelling 100

Fierce Pharma

OCTOBER 25, 2023

Five months after becoming the first company to secure FDA approval for a respiratory syncytial virus (RSV) vaccine, GSK is taking steps toward expanding its label for Arexvy. The company has revealed that a study investigating Arexvy’s effectiveness in adults ages 50 to 59 has achieved its two primary objectives.

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Labelling Vaccines FDA 87

STAT

MARCH 30, 2023

Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding threatens the availability of lower-cost generic drugs. solicitor general urged the U.S.

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Labelling 102

Drug Topics

JULY 12, 2023

Recent safety data also allowed four adverse events to be removed from the label.

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Labelling 98

BioPharm

SEPTEMBER 18, 2023

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

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Labelling Documentation FDA 52

BuzzRx

JANUARY 27, 2023

The term “on-label use” of a drug may seem unfamiliar to most people. In short, this practice is referred to as “off-label” drug use. Surveys have shown that approximately 1 in 5 prescriptions in the US are for off-label use. In certain populations of patients, off-label drug use is even higher.

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Labelling Dosage FDA Pharmaceutical Companies 52

Pharmacy Times

DECEMBER 5, 2023

The approval marks levothyroxine sodium as the only FDA-granted LT4 therapy that does not have a labeled interaction with PPIs and can be taken 15 minutes prior to eating breakfast.

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Labelling FDA 65

Drug Store News

DECEMBER 7, 2022

L’Oréal’s Product Impact Labeling gives items a ranking on a scale from A to E by considering 14 planetary impact factors.

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Labelling 105

pharmaphorum

JUNE 6, 2023

ASCO: Enhertu data sets up tumour-agnostic label bid Phil.Taylor Tue, 06/06/2023 - 08:26 Bookmark this

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Labelling 92

Drug Store News

OCTOBER 19, 2022

Lannett's deal call for another pharmaceutical company to purchase and distribute under a private label a limited number of certain other Lannett owned generic drug products.

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Labelling Pharmaceutical Companies Pharmaceutical Companies 98

STAT

AUGUST 21, 2023

A 2019 policy requires companies that make unhealthy foods to include warning labels on the front of any boxes they sell in Mexico to educate consumers about things like excess sugar and fat. MEXICO CITY — Kellogg’s is waging a war here over Tigre Toño and Sam el Tucán.

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Labelling Packaging FDA 98

Drug Store News

JULY 6, 2023

Several beauty trends will be revealed at PLMA’s 2023 annual Private Label Trade Show, Nov. 12-14 in Chicago.

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Labelling 98

Pharmaceutical Commerce

JULY 10, 2023

Platform is expected to streamline the label management process.

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Labelling 73

Fierce Pharma

MAY 15, 2023

UPDATED: After Supreme Court rejection, Teva mulls options in GSK 'skinny label' feud fkansteiner Mon, 05/15/2023 - 10:59

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Labelling 105

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

Roots Analysis

MARCH 8, 2023

In recent years, the use of smart labels allows the developer to convey a greater amount of information about the product to the consumers, without the need for additional packaging space. Further, smart labels play a critical role in the manufacturing of pharmaceuticals.

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Labelling Communication Packaging 52