PharmExec

OCTOBER 8, 2024

Laura Johnson, senior director, sales, life sciences, Loftware, discusses scenarios where unclear labeling led to challenges for patient outcomes.

Labelling 52

Labelling 52

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 120

Labelling FDA 120

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 107

Labelling FDA 107

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 63

Labelling 63

PharmExec

OCTOBER 2, 2024

Laura Johnson, senior director, sales, life sciences, Loftware, discusses issues faced by the pharmaceutical industry when it comes to proper drug labeling.

Labelling 52

Labelling 52

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 114

Labelling FDA 114

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 56

Labelling 56

Pharmaceutical Technology

SEPTEMBER 20, 2024

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended an update to Novo Nordisk’s Wegovy label.

Labelling 52

Labelling 52

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 139

Labelling FDA 139

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 134

Labelling FDA 134

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 130

Labelling Hospitals 130

Pharmaceutical Technology

SEPTEMBER 18, 2023

The FDA released a draft guidance giving advice on the correct labelling of biosimilar and interchangeable biosimilar products.

Labelling 105

Labelling FDA 105

The Checkup by Singlecare

JUNE 20, 2024

This is called off-label prescribing , and SSRIs rank among the top use cases for off-label use. Pharmacists, in particular, should be familiar with off-label uses of SSRIs, as you may come across off-label prescriptions in everyday practice. These are some of the common off-label uses for SSRIs.

Labelling 52

Labelling Dosage FDA 52

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.

Labelling 122

Labelling 122

Fierce Pharma

AUGUST 16, 2024

Months after securing the full rights to anti-CD19 antibody Monjuvi (tafasitamab) from partner MorphoSys, Incyte has the data to potentially back a label expansion into lymphoma. | The company looks to file its drug for a follicular lymphoma indication as part of a later-line triple combo therapy by the end of the year.

Labelling 75

Labelling 75

Pharmaceutical Technology

OCTOBER 24, 2023

The FDA released a draft guidance giving firms recommendations on provider-directed communication for off-label drug use.

Labelling 98

Labelling FDA Communication 98

pharmaphorum

AUGUST 2, 2023

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

Labelling 98

Labelling 98

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.

Labelling 113

Labelling Generic Medicine 113

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. 

Labelling 123

Labelling Chemotherapy FDA Patient Care 123

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.

Labelling 101

Labelling 101

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.

Labelling 97

Labelling 97

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

pharmaphorum

JUNE 14, 2024

FDA widens label for BMS’ cancer drug Augtyro Phil.Taylor Fri, 14/06/2024 - 08:17 Bookmark this

Labelling 86

Labelling FDA 86

Pharmaceutical Technology

JUNE 12, 2024

Written Medicine is a digital solution that provides bilingual dispensing labels, described in a presentation at the NHS ConfedExpo conference in Manchester.

Labelling 52

Labelling 52

pharmaphorum

AUGUST 25, 2023

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

Labelling 98

Labelling 98

pharmaphorum

JUNE 28, 2023

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

Labelling 98

Labelling 98

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.”

Labelling 72

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.

Labelling 98

Labelling 98

Pharmacy Times

JANUARY 19, 2024

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

Labelling 65

Labelling 65

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.,

Packaging 98

Packaging Labelling Grocery Stores FDA 98

Pharmaceutical Technology

MARCH 25, 2024

Download our extensive, free list of the leading pharmaceutical packaging companies and labelling machine manufacturers today.

Packaging 52

Packaging 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.

Labelling 74

Labelling FDA 74

Pharmaceutical Technology

JUNE 21, 2024

Sarepta’s stock rose by over 36% following the positive news of the FDA expanding the gene therapy’s US label.

Labelling 52

Labelling FDA 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

Labelling 103

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 97

Labelling 97

Pharmaceutical Technology

MARCH 29, 2024

Revolutionize your labeling process with Angelini Spa's patented method using a robot and label printer to efficiently attach printed labels to reels. Patent Publication Number: US11884443B2.

Labelling 52

Labelling 52

Drug Topics

JULY 12, 2023

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

Labelling 98

Labelling 98