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

Drug Topics

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 201
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Sarepta scores 'transformational' FDA label expansion for Duchenne gene therapy Elevidys

Fierce Pharma

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 125
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Sarepta bags key expansion to DMD gene therapy label in US

pharmaphorum

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

Labelling 111
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STAT+: Obesity drug Wegovy gets FDA approval to add cardiovascular benefits on its label

STAT

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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Can Patient-Centered Prescription Labels Increase Medication Adherence?

Drug Topics

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

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

pharmaphorum

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 119
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FDA widens label for BMS’ cancer drug Augtyro

pharmaphorum

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