BridgeBio wins FDA approval for inherited cardiomyopathy treatment
California-based BridgeBio has secured US FDA approval for its lead candidate drug, acoramidis (brand name Attruby) for treatment of transthyretin amyloid cardiomyopathy (ATTR-CM), an inherited heart condition.
FDA Approves First ‘Near-Complete’ Stabilizer to Treat ATTR Cardiomyopathy
Acoramidis becomes the second drug ever approved for this condition, based on the results of the ATTRibute-CM trial.
Days After BridgeBio Approval, FDA Agrees to Review Alnylam’s Amvuttra in ATTR-CM
The FDA has accepted Alnylam’s supplemental New Drug Application for Amvuttra on the heels of BridgeBio’s Attruby nod, potentially giving Pfizer’s tafamidis franchise another competitor.
FDA Approves Attruby for Hearth Failure Indication
Attruby (acoramidis) is a small molecule approved to treat adults with transthyretin amyloid cardiomyopathy. It will have a list price of $18,759 for a month’s supply.
Bridgebio’s Attruby, to Treat Heart Condition ATTR-CM, Receives FDA Approval
Attruby (acoramidis), a near complete TTR stabilizer, has been approved by FDA to reduce cardiovascular death and hospitalization in ATTR-CM patients.
FDA accepts Alnylam’s sNDA for vutrisiran for ATTR-CM treatment
Pharmaceuticals announced that the U.S. Food and Drug Administration or FDA, has accepted for review the Company’s supplemental
BridgeBio Pharma Gets FDA Approval for Heart Disease Drug Attruby
The Palo Alto, California-based biopharmaceutical company said the Food and Drug Administration approved Attruby for adults with transthyretin amyloid cardiomyopathy, or ATTR-CM, to reduce cardiovascular death and cardiovascular-related hospitalization.
FDA approves BridgeBio’s Attruby for ATTR-CM treatment
Attruby is the first approved product with a label that specifies near-complete TTR stabilisation. The approval triggers a $500m payment to BridgeBio under a royalty funding agreement. The ATTRibute-CM Phase III trial,
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FDA Approves New Drug for Life-Threatening Heart Condition
The FDA has approved Attruby, a new oral treatment that helps reduce heart-related deaths and hospital visits among adults ...
FDA approves Palo Alto biotech's heart disease drug
The stock market responded positively to the company's announcement, with its share price leaping more than 28% following the ...
BridgeBio Soars After Drug Gets Nod in Rare Heart Condition
BridgeBio Pharma Inc. gained US approval for a drug to treat a progressive and deadly form of heart disease, paving the way ...
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Attruby Approved for Cardiomyopathy of Transthyretin-Mediated Amyloidosis
The Food and Drug Administration (FDA) has approved Attruby TM (acoramidis) for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to ...
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BridgeBio Stock Hits 2-Month Highs After Analysts Cheer FDA Nod For Heart Drug: Retail Excitement Builds
BridgeBio Pharma Inc. ($BBIO) stock surged 28% on Monday morning, hitting highs last seen in mid-September, after the company ...
Intellia Gets RMAT Designation From FDA For Nex-z In ATTR Amyloidosis With Polyneuropathy; Stock Up
Intellia Therapeutics, Inc. (NTLA), a clinical-stage gene editing company, Monday said that the U.S. Food and Drug Administration or ...
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Vutrisiran Under Review for Transthyretin Amyloid Cardiomyopathy
Vutrisiran, a transthyretin-directed small interfering RNA therapeutic, is currently approved under the brand name Amvuttra ® for the treatment of polyneuropathy manifestations of hereditary ...