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.
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.
US FDA approves BridgeBio's drug for rare heart condition (Nov 22)
Pfizer's drug to about $268,000, not $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, the company said on Friday,
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 Pfizer-Rivaling Heart Drug
BridgeBio Pharma snagged FDA approval for its rival to Pfizer's heart disease treatment, Vyndaqel. BridgeBio stock catapulted.
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FDA Investigating Blood Cancer Risk With Gene Therapy Skysona
The FDA said on Wednesday that it is investigating reports of blood cancers -- including life-threatening cases of ...
Soup Recall Update as FDA Sets Highest Risk Level
A soup mix recall issued this month has been updated by the U.S. Food and Drug Administration ( FDA) as a Class I risk, the ...
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 ...
Carrots, ice cream and more items recalled by the FDA. Here's the list for November 2024
Here's a list of what was pulled from stores in November 2024. The FDA removed the following items from store shelves in ...
RFK Jr. ‘very well aligned’ with FDA mission on diet-related chronic disease: fmr. FDA official
A recent slew of food recalls is raising questions about the government’s ability to ensure food safety. Former FDA official Susan Mayne and New York Times reporter Christina Jewett join Meet the ...
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COVID or Flu? This New FDA-Authorized, At-Home Test Will Tell You
You can now purchase a test that will tell you whether you are sick with COVID or the flu -- no prescription required.
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 ...
FDA Expands Carrot Recall Linked to E. Coli: 39 Illnesses, 15 Hospitalizations Reported
The FDA expanded the recall on November 21 after 39 cases of illness, resulting in 15 hospitalizations and one death, have ...
FDA proposes removal of common decongestant
“Phenylephrine is an oral decongestant and vasoconstrictor,” Valley Health Pharmacist Dr. Aaron Stone. “By that, it means it ...
Makary for FDA. Here’s what you need to know.
President-elect Donald Trump’s Friday night news dump of health care nominees included the expected naming of Dr. Marty ...
Seafood Recall Update As FDA Sets Risk Level
The seafood salad may be of particular risk to those customers who have an allergy or severe sensitivity to soy, the FDA has ...
Exclusive: Thousands turn to Wegovy copies each month as FDA considers shortage status
More than 200,000 prescriptions for copies of Novo Nordisk's weight-loss drug Wegovy are getting filled by U.S. patients each ...