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)
(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 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.
US says a drug cartel is behind the longstanding problem of illegal fishing in the Gulf of Mexico
For years, U.S. authorities and fishermen have complained about illegal fishing for red snapper in the Gulf of Mexico, and ...
Exclusive: US FDA finds widely used asthma drug impacts the brain
U.S. government researchers have found that a widely prescribed asthma drug originally sold by Merck & Co may be linked to ...
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 ...
Trump's Pick for FDA to Test 'Due Diligence' of Agency's Science
Marty Makary, an outspoken critic of the nation’s food and drug regulator, stands to shake up the FDA’s standards in science ...
Are food recalls and outbreaks on the rise? FDA says U.S. food supply still "one of the safest in the world"
The FDA says America's food supply is still "one of the safest in the world," despite some recent high-profile recalls and ...
The American Journal of Managed Care19h
US ADHD Stimulant Shortage Highlights Growing Challenges in Adult Treatment
While name brands like Adderall and Vyvanse may have been recently removed from the FDA Drug Shortage Database, it's unclear ...
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 ...
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 ...