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 ...
US FDA approves BridgeBio's drug for rare heart condition (Nov 22)
The U.S. Food and Drug Administration has approved BridgeBio's drug for a rare and deadly heart condition, the company said ...
WebMD2d
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 ...
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 ...
FierceBiotech20h
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 ...
STAT5d
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 ...
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 ...
GlobalData on MSN2d
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.
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 ...
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 ...
The American Journal of Managed Care2d
FDA Advised to Update Labels on GLP-1 Weight-Loss Drugs
In the US, liraglutide, semaglutide, and tirzepatide are currently under investigation for their ability to stimulate weight ...
JD Supra13h
FDA Provides Perspective on Goals and Challenges for Regulation of Artificial Intelligence in Medical Devices, Drug Design, and Clinical Research
A recent article authored by Haider J. Warraich, MD; Troy Tazbaz; and Robert M. Califf, MD in the Journal of the American ...