US FDA declines full approval for Intercept's liver disease drug
By Bhanvi Satija and Puyaan Singh (Reuters) - The U.S. Food and Drug Administration on Tuesday declined full approval for ...
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US FDA approves PTC Therapeutics' gene therapy for ultra-rare disorder
Nov 13 (Reuters) - The U.S. Food and Drug Administration approved PTC Therapeutics' (PTCT.O), opens new tab gene therapy to ...
US FDA lifts clinical hold on Novavax's combo COVID-flu shot
The U.S. Food and Drug Administration has lifted its clinical hold on a late-stage trial of Novavax's COVID-influenza and its ...
How Safe Is US Food? Experts' Verdicts After Listeria, E. Coli Outbreaks
Recently, two notable incidents—a listeria outbreak involving ready-to-eat meat products and an E. coli outbreak tied to ...
US FDA approves Johnson & Johnson's device for heart condition
The U.S. Food & Drug Administration has approved Johnson & Johnson's device for a type of condition which causes abnormal ...
US overdose deaths are down, giving experts hope for an enduring decline
In the latest CDC data, overdose death reports are down in 45 states. Increases occurred in Alaska, Nevada, Oregon, Utah and ...
JD Supra1d
How the US Election May Affect the FDA Regulation of Life Sciences Products – Key Areas to Watch
The reelection of former President Donald Trump, coupled with Republicans gaining the Senate majority and poised to gain the House majority, ...
STAT2d
Risk of aspiration during surgery added to GLP-1 drug labels
The FDA updated GLP-1 drug labels to warn of the risk of patients breathing food into their lungs while under anesthesia for ...
Independent pharmacists blame ‘medical middlemen’ for soaring drug costs, pharmacy closures
NEW ORLEANS (WVUE) - If you have trouble affording prescription drugs, some independent pharmacists say that so-called ...
STAT1d
Pharmalittle: We’re reading about 23andMe retrenching, AstraZeneca reworking cancer drug plans, and more
In closing its therapeutics division and laying off 200 people, 23andMe ended an audacious bet it made nearly a decade ago — ...
Man who allegedly led Morgantown drug ring admits to trafficking charges
A Philadelphia man who law enforcement officers say led a Morgantown-based drug ring has admitted to his role in trafficking ...
FiercePharma13d
UPDATED: FDA lists all doses of Novo's Wegovy as available, signaling potential end to semaglutide supply rout in US
Less than a month after the FDA removed Eli Lilly’s tirzepatide from its shortage list, the agency has done the same for Novo Nordisk’s rival GLP-1 semaglutide, potentially signaling the end of a d | ...