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.
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 ...
MedPage Today3h
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 ...
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 ...
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 ...
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 ...
CNET on MSN12h
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.
FDA proposes removal of common decongestant
“Phenylephrine is an oral decongestant and vasoconstrictor,” Valley Health Pharmacist Dr. Aaron Stone. “By that, it means it ...
FierceBiotech11h
Outlook's stock plummets after eye drug fails to match Lucentis, but biotech still plans FDA filing
Outlook Therapeutics’ eye disease drug has failed to match Roche’s Lucentis in a key trial. The biotech brushed off the ...
Applied Therapeutics Down 76% After Hours on FDA Complete Response Letter
An FDA complete response letter indicates that an application can't be approved in its current form. Govorestat, the company's lead drug candidate, is also being developed for treatment of sorbitol ...
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 ...
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 ...
Applied Therapeutics Receives FDA Complete Response Letter for Govorestat New Drug Application
Applied Therapeutics said it has received a complete response letter from the Food and Drug Administration related to its new drug application for govorestat due to deficiencies in the clinical ...