Amgen gets expanded FDA label approval for Uplizna
Amgen (NASDAQ: NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has granted an expanded label approval ...
Amgen announces FDA approval of Uplizna
Amgen (AMGN) announced that the U.S. FDA has approved Uplizna as the first and only treatment for adults living with Immunoglobulin G4-related ...
US FDA approves Amgen's Uplizna as first treatment for rare immune disorder
The U.S. Food and Drug Administration has approved expanded use of Amgen's drug, Uplizna, to help reduce the risk of flares ...
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What Happens When Drugs Fail Post-Approval?
This article examines post-market drug safety, highlighting surveillance mechanisms, regulatory responses, and case studies of approved drugs with hidden risks.
Supreme Court upholds FDA decision to ban flavored vapes
The Supreme Court on Wednesday threw out an appeals court ruling that found the FDA unlawfully handled approval requests made ...
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Supreme Court Sides With the FDA in Its Dispute Over Sweet-Flavored Vaping Products
The high court upheld the agency's authority to deny marketing applications for flavored e-cigarettes amid youth vaping concerns.
Supreme Court largely backs Biden-era FDA on flavored vapes
The US Supreme Court largely sided with the Food and Drug Administration in its rejection of applications to sell flavored ...
Unanimous Supreme Court upholds FDA block of flavored vapes
The Supreme Court backed the FDA's refusal to authorize the sale of kid-friendly flavored vapes, including the flavors ...
U.S. Supreme Court backs up FDA rejection of marketing flavored vapes to youth
The U.S. Supreme Court on Wednesday upheld an FDA decision that rejected a series of applications to market fruit-flavored ...
Novavax believes BLA ‘ready for approval,’ waiting on action from FDA
Novavax (NVAX) issued the following update on the FDA BLA for the company’s COVID-19 vaccine: “Novavax can confirm that April 1, 2025, was the ...
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US FDA approves first treatment for hyperphagia in Prader-Willi syndrome
The United States Food and Drug Administration (US FDA) has approved VYKAT™ XR, a significant milestone as the first approved treatment for hyperphagia in Prader-Willi syndrome (PWS).