Novo Nordisk asks FDA to ban compounding pharmacies from making Ozempic, Wegovy copies
The Danish drugmaker Novo Nordisk argues that semaglutide, the active ingredient in Ozempic and Wegovy, are too complex for ...
US FDA approves Pfizer's RSV vaccine for adults at increased risk of the disease
The U.S. Food and Drug Administration on Tuesday approved Pfizer's RSV vaccine for the prevention of lower respiratory tract ...
Pfizer Receives FDA Approval for RSV Vaccine
Abrysvo can prevent lower respiratory tract disease caused by RSV for people between the ages of 18 and 59 who are at ...
US FDA declines to approve Camurus' rare hormone disorder drug
The U.S. Food and Drug Administration has declined to approve Camurus' drug for the treatment of a rare hormonal disorder due ...
FDA Has Recalled Thousands of Bottles of Antidepressant Duloxetine, Sold Under Brand Name Cymbalta: Here’s Why
The Duloxetine Delayed-Release Capsules' voluntary recall began on Oct. 10 after the FDA deemed the medication the ...
Injectable drug to ease advanced Parkinson's disease symptoms approved by FDA
The FDA on Thursday approved an injectable drug that eased Parkinson's disease symptoms and improved motor fluctuations in ...
Amid backlash, FDA changes course over shortage of weight-loss drugs
The FDA said Eli Lilly’s weight-loss drugs were no longer in shortage on Oct. 2, preventing pharmacies from making cheaper ...
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Novo Makes Case to FDA That Semaglutide Is Too Complex for Compounders to Produce
Novo Nordisk has nominated semaglutide for inclusion in the FDA’s Demonstrable Difficulties for Compounding list, which ...
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FDA approves Pfizer's RSV shot Abrysvo for all at-risk adults
While it’s a win for Pfizer over GSK and its RSV vaccine Arexvy, which is approved for those 50 and older, it’s difficult to ...
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FDA and Industry Experts Unpack Biosimilar Device Requirements
At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for ...
Cookies Recall Update as FDA Sets Highest Risk Level
More than 10,000 packages of cookies have been recalled after they were found to contain an undeclared allergen. In September ...
Her breast density camouflaged her cancer. She says new FDA regulations are "a gift."
"If I have dense breast tissue, am I more prone to get cancer?" CBS News New York's Kristine Johnson asked. "The answer is, ...