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Novartis' Pluvicto enters FDA orbit for expansion bid as agency requests 'flexibility'

Fierce Pharma

As expected, Novartis’ radioligand therapy Pluvicto crossed the blockbuster sales threshold with one quarter still left of 2024. The company made the decision in response to the FDA's request for "flexibility" in its review timeline, Novartis CEO Vas Narasimhan explained.

FDA 250
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FDA unleashes multiple warning letters targeting insanitary manufacturing and online sales of unapproved Mounjaro, Ozempic

Fierce Pharma

FDA unleashes multiple warning letters targeting insanitary manufacturing and online sales of unapproved Mounjaro, Ozempic fkansteiner Wed, 02/14/2024 - 05:10

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Sparked by FDA expansion, Sarepta's Elevidys takes another leap in sales

Fierce Pharma

An FDA expansion of Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) Elevidys has sparked a new surge in sales for the gene therapy. | An FDA expansion of Sarepta Therapeutics’ Duchenne muscular dystrophy Elevidys has sparked a new surge in sales.

Sales 206
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AbbVie's Vraylar, carrying $4B sales target, wins FDA label expansion in depression

Fierce Pharma

AbbVie's Vraylar, carrying $4B sales target, wins FDA label expansion in depression. Mon, 12/19/2022 - 11:13.

Sales 225
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AbbVie's Skyrizi proves a worthy Humira successor with nearly matching sales ahead of potential UC nod

Fierce Pharma

AbbVie’s immunology heirs Skyrizi and Rinvoq are proving booming growth to make up for once-king Humira’s continuous sales slide. | As Humira continues its sales free fall, newer Skyrizi is proving a worthy successor with nearly matching sales ahead of an upcoming FDA decision in ulcerative colitis.

Sales 241
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With new FDA approval, Merck's Welireg takes another step toward blockbuster goal

Fierce Pharma

Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely. Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely.

FDA 281
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FDA rebuffs Amneal's Parkinson's prospect with $500M peak sales target

Fierce Pharma

Amneal Pharmaceuticals’ hopes for a midyear launch of its extended-release Parkinson’s disease prospect—and a shot at a potential $500 million peak sales opportunity in the U.S.—have