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Madrigal, FDA approval in hand, outlines plan to sell MASH drug

BioPharma Drive: Drug Pricing

The company expects initial uptake of Rezdiffra, which costs $47,400 per year, to be slow as doctors and insurers establish the protocols needed to find patients eligible for treatment.

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FDA Approves AI Device That Helps Spot Skin Cancer

Drugs.com

18, 2024 (HealthDay news) -- The first medical device powered by artificial intelligence and designed to help doctors catch skin cancer has been approved by the U.S. THURSDAY, Jan. Food and Drug Administration.Although not meant to be used as a.

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FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog: Biosimilars

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. That requirement would only be fulfilled if FDA agreed to such a change. But we digress. And indeed, after Pliva v.

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ABBOTT RECEIVES FDA APPROVAL FOR TACTIFLEX™ ABLATION CATHETER FOR TREATMENT OF ABNORMAL HEART RHYTHM

The Pharma Data

ABBOTT RECEIVES FDA APPROVAL FOR TACTIFLEX™ ABLATION CATHETER FOR TREATMENT OF ABNORMAL HEART RHYTHM Abbott (NYSE: ABT) today announced that the U.S. 6 “Abbott is leading the way in helping doctors manage common arrhythmias with the most holistic portfolio for this condition in the world,” said Christopher Piorkowski, M.D.,

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FDA Approves J&J’s Darzalex Faspro for Rare Light Chain Amyloidosis

The Pharma Data

Food and Drug Administration (FDA) approved Janssen Pharmaceuticals ’ (a Johnson and Johnson company) Darzalex Faspro for adults with newly diagnosed light chain amyloidosis. It was approved in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd). Michael Vi/Shutterstock. It was developed with Genmab.

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ABBOTT RECEIVES FDA APPROVAL FOR ITS SPINAL CORD STIMULATION SYSTEMS TO TREAT CHRONIC BACK PAIN IN PEOPLE WHO HAVE LIMITED SURGICAL OPTIONS

The Pharma Data

ABBOTT RECEIVES FDA APPROVAL FOR ITS SPINAL CORD STIMULATION SYSTEMS TO TREAT CHRONIC BACK PAIN IN PEOPLE WHO HAVE LIMITED SURGICAL OPTIONS Abbott (NYSE: ABT) announced today that the U.S. More than 50 million people in the U.S. suffer from chronic pain. 5 According to the U.S.

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FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD)

The Pharma Data

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.