US FDA declines to approve Applied Therapeutics' genetic disease drug
Applied Therapeutics said on Wednesday that the U.S. FDA declined to approve its drug to treat galactosemia, a rare genetic metabolic disease, casting a cloud over the company's hopes for its first commercial product.
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.
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,
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.
What The FDA Gets Wrong About Drug Ads
Regulators need to know that our most important health care problem is not that people are taking too many prescription drugs ...
Jazz Pharmaceuticals receives FDA approval for biliary tract cancer treatment
The U.S. Food and Drug Administration approved Jazz Pharmaceuticals' drug, zanidatamab-hrii, for the treatment of a type of ...
Cure Today2d
FDA Accepts New Drug Application for Nubeqa Combo for Prostate Cancer Subset
The FDA will review an application to consider potential approval of Nubeqa plus androgen deprivation therapy for metastatic ...
STAT8d
The FDA’s risky action on compounding weight loss drugs
The FDA’s decision to allow the compounding of GLP-1 weight loss drugs could undermine its public health obligations, writes ...
FDA probes blood cancer risk from bluebird's gene therapy, weighs regulatory action
The U.S. Food and Drug Administration is weighing the need for a regulatory action on bluebird bio's gene therapy for a rare ...
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 ...
A Short Lesson in Drug Competition
See the new treatment that will break a Pfizer monopoly on a drug for heart disease.
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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.
Vivek Ramaswamy’s crusade to change FDA could boost biotech, and himself
The co-leader of President-elect Donald Trump’s initiative to cut government spending has a financial stake in the biotech ...