FDA, BridgeBio

US FDA approves BridgeBio's drug for rare heart condition (Nov 22)
(In Nov. 22 story, corrects list price of Pfizer's drug to about $268,000 from $225,000 in paragraph 3) (Reuters) -The U.S. Food and Drug Administration has approved BridgeBio's drug for a rare and deadly heart condition,
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.
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 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 FDA approval ‘significant clearing event,’ says Citi
Citi analyst David Lebowitz keeps a Buy rating on BridgeBio (BBIO) with a $45 price target after the FDA granted approval for Attruby for
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.
BridgeBio Soars After Drug Gets Nod in Serious Heart Condition
BridgeBio Pharma Inc. jumped in premarket trading after its drug got US regulators’ nod to treat a deadly form of heart disease, paving the way for head-to-head competition with medications from Pfizer Inc.
BridgeBio Catapults After Snagging Approval For Its Rival To Pfizer's Heart Drug
BridgeBio Pharma snagged FDA approval for its rival to Pfizer's heart disease treatment, Vyndaqel. BridgeBio stock catapulted.
FDA approves Bimzelx for hidradenitis suppurativa
The U.S. Food and Drug Administration has approved UCB's Bimzelx (bimekizumab-bkzx) for the treatment of adults with moderate ...
Managed Healthcare Executive2d
FDA Approves New Imatinib Oral Solution
Imkeldi is a new formulation of imatinib approved as a strawberry-flavored, shelf-stable liquid designed to be more appealing ...
The American Journal of Managed Care2d
FDA Approves Imatinib Oral Solution for Treatment of Various Cancers
The oral solution offers precise dosing, benefiting patients with swallowing difficulties or requiring tailored dosing.
FDA approves Kebilidi for aromatic L-amino acid decarboxylase deficiency
The U.S. Food and Drug Administration has approved PTC Therapeutics' Kebilidi (eladocagene exuparvovec-tneq) for the ...
GlobalData on MSN3d
LifeSignals gains FDA approval for wearable biosensor
The UbiqVue 2A multi-parameter system biosensor is worn on the chest and collects biodata across 13 monitored parameters.
Yahoo7d
Novocure secures FDA approval for add-ons to brain cancer treatment wearable
FDA approval on the refined HFEs for Optune Gio follows the agency’s recent approval on another TTField-emitting ...
The American Journal of Managed Care3d
FDA Approves Acoramidis for ATTR-CM
With approval, acoramaidis (Attruby; BridgeBio Pharma) becomes the first agent with a label specifying near-complete ...
Pharmaceutical Technology16h
CervoMed’s stock rises as FDA grants orphan drug status to dementia drug
There are currently no FDA- or EMA-approved treatment options available for any form of frontotemporal dementia.