Drug acoramidis to treat rare heart disease approved by FDA
The U.S. Food and Drug Administration has approved a drug developed at Stanford Medicine that offers hope to people diagnosed ...
InnovationRx: FDA Issues New Guidance For AI In Medical Devices
This week, the FDA issued recommendations for streamlining the clearance process for AI-powered medical devices. The memo announcing this change recognizes that the utilization of AI in devices “is an ...
A Short Lesson in Drug Competition
See the new treatment that will break a Pfizer monopoly on a drug for heart disease.
Biotech Stock Roundup: BBIO Stock Up on Drug Approval, SAVA, APLT Plunge on Setbacks & More
Failed to fetch dynamically imported module: https://finance.yahoo.com/assets/_app/immutable/nodes/90.BMDkfsfZ.js ...
STAT6d
BridgeBio wins FDA approval for heart disease drug
The drug, known scientifically as acoramidis, will be sold by BridgeBio under the brand name Attruby. The FDA cleared Attruby to treat patients with the heart condition known as transthyretin ...
The Pharma Letter3d
The week in pharma: action, reaction and insight – week to November 29
Among important regulatory news last week, US drugmaker BridgeBio Pharma gained Food and Drug Administration (FDA) approval ...
pharmaphorum2d
BridgeBio poised to challenge Pfizer after Attruby approval
Acoramidis has been cleared under the Attruby brand name as an oral therapy to reduce cardiovascular death and cardiovascular-related hospitalisation in adults with ATTR-CM, a progressive disease ...
Wall Street Journal6d
A Short Lesson in Drug Competition
BridgeBio’s Attruby may be even more effective. The twice a day pill regimen reduced the risk of death and recurrent cardiovascular hospitalizations by 42% after 30 months of treatment.