BridgeBio, Food and Drug Administration

US FDA approves BridgeBio's drug for rare heart condition
The U.S. Food and Drug Administration has approved BridgeBio's drug for a rare and deadly heart condition, the company said on Friday, making it the first new treatment in a market dominated by Pfizer's blockbuster Vyndaqel.
BridgeBio Pharma : FDA Approves Heart Disease Drug 'acoramidis'
BridgeBio Pharma Inc. (BBIO) announced that the U.S. Food and Drug Administration approved Attruby or acoramidis, an
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.
BridgeBio Gets US Approval for Heart Drug to Compete with Pfizer
BridgeBio Pharma Inc. gained US approval for a drug to treat a progressive and deadly form of heart disease, paving the way for the biotech company to go head-to-head with Pfizer Inc. in an increasingly competitive market.
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 announces FDA approved Attruby for ATTR-CM patients
Pharma announced that the U.S. Food and Drug Administration approved Attruby, an orally-administered near-complete stabilizer of
BridgeBio Wins FDA Approval for ATTR-CM Drug, Launching Competition with Pfizer
Experts view BridgeBio’s acoramidis—which has an FDA action date of Nov. 29—as either similar to or incrementally better than Pfizer's already established tafamidis.
BridgeBio: 2 Weeks Until Major Drug Approval Catalyst - A Buy, With Caveats
BridgeBio Pharma’s acoramidis shows improved survival data, boosting approval chances. Read why BBIO stock could see gains if FDA greenlights the drug.
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Revolutionary Drug Approvals and Global Health Updates
The latest health news highlights BridgeBio's new heart drug approved by the FDA, novel findings in breast cell research, ...
FierceBiotech5d
Nearing potential FDA approval, BridgeBio shows additional positive data on ATTR-CM candidate acoramidis
An open-label extension study of the phase 3 ATTRibute-CM trial shows that acoramidis produced reductions of 36% and 34% in ...
Morningstar11d
No-Moat BridgeBio's Valuation Driven by Pending Approval of Acoramidis; Positive Long-Term Outlook
The Food and Drug Administration has accepted BridgeBio’s new drug application for acoramidis with a Prescription Drug User Fee Act action date set for Nov. 29. If it receives regulatory ...
devdiscourse23h
FDA's Game-Changing Approvals and Global Health Alerts
The latest health news highlights FDA's approval of BridgeBio's drug for a rare heart condition, cancer features in healthy ...