BridgeBio Stock Up on FDA Approval of Cardiovascular Drug
BridgeBio Pharma, Inc. BBIO recently announced that it obtained FDA approval for its pipeline candidate acoramidis for the treatment of adults with transthyretin amyloidosis cardiomyopathy (ATTR-CM) to reduce cardiovascular death and cardiovascular-related hospitalization.
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 with transthyretin amyloid cardiomyopathy, or ATTR-CM.
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 opening bell Monday.
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.
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.
BridgeBio heart drug approved by FDA, setting up battle with Pfizer
The approval of Attruby for transthyretin amyloidosis with cardiomyopathy begins a battle for control of a lucrative market that investors have been skeptical BridgeBio can win.
BridgeBio wins FDA approval for heart disease drug
The Food and Drug Administration approved on Friday a new medicine from BridgeBio for patients with a progressive heart disease — the first new treatment for the condition in over five years and the company’s first significant commercial product. The drug, known scientifically as acoramidis, will be sold by BridgeBio under the brand name Attruby.
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 Begins Review of Alnylam's sNDA for Expanded Amvuttra Use
Alnylam Pharmaceuticals ALNY announced that the FDA has accepted its supplemental new drug application (sNDA) seeking the ...
Ultromics obtains Breakthrough Device FDA clearance for its Cardiac Amyloidosis screening device through the Total Product Lifecycle Advisory Program
Ultromics' EchoGo® Amyloidosis, clinical AI for echocardiography with the potential to revolutionize early detection of ...
BioWorld4d
Ultromics’ AI software for cardiac amyloidosis gets FDA approval
Ultromics Ltd. received clearance from the U.S. FDA for Echogo Amyloidosis, its artificial intelligence-enhanced software ...
Pfizer meets amyloidosis rival as BridgeBio wins FDA nod for Attruby
BridgeBio Pharma (BBIO) wins FDA nod Attruby for rare heart disorder, ATTR-CM challenging Pfizer's (PFE) Vyndaqel. Read more ...
TCTMD6d
Novel CRISPR-Cas9 Therapy Slows ATTR-CM Progression
By targeting the TTR gene directly in the liver, the therapy “has opened up the door” to permanent treatment, says Sarah ...