Scientist whose work led FDA to ban food dye says agency overstated risk
When the FDA announced in January, before President Joe Biden's term ended, that it would ban a dye called red dye No. 3 in ...
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HHS OIG Reviews FDA’s Accelerated Approval of Aducanumab
conducted a review of the Food and Drug Administration (FDA) accelerated approval pathway for prescription drugs, to better understand the extent to which the FDA’s review varied throughout the ...
Armed robbery in Revesby14d
Triple Combo Drug Approved for Cystic Fibrosis
In two randomised phase 3 studies involving 480 participants aged 12 years and over, ivacaftor/tezacaftor/vanzacaftor was found to be as effective at improving lung ...
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Trump’s FDA nominee faces Senate questions after agency layoffs and resignations
including telehealth and drug companies that sell compounded versions of FDA-approved drugs. The Associated Press Health and Science Department receives support from the Howard Hughes Medical ...
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FDA Drug Approval Decisions Expected in March 2025
The FDA is reviewing the application for bentracimab for use as a ticagrelor reversal agent in patients with uncontrolled bleeding or in those who require urgent surgery or invasive procedure.
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Pixel Watch 3 gets FDA approval to alert you if you’re dying
Google wasn't allowed to unlock that feature in the US until it got regulatory approval, but the Food and Drug Administration has finally given Google the go-ahead to activate Loss of Pulse Detection.
dvm36024d
Second drug for canine healthy lifespan extension receives FDA support
A developmental drug that aims to extend the healthy lifespan of senior dogs has received acceptance by the FDA’s Center for Veterinary Medicine for the Reasonable Expectation of Effectiveness (RXE) ...
BioSpace24d
How SpringWorks Took Pfizer’s Rare Disease Ghost Drug and Got It to Patients
This method could work for “every rare disease under the sun,” advocates say. Every drug approval is a monumental occasion worthy of celebration. But for SpringWorks Therapeutics, the approval of rare ...
WebMD25d
FDA Approves New Label for Opioid Use Disorder Drug
Feb. 25, 2025 – The FDA has approved a new treatment plan for a long-acting injection, making it easier for people with moderate to severe opioid use disorder (OUD) to start and keep up with ...
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First drug shown to reverse feline HCM expected to receive FDA conditional approval
The drug’s major success in clinical trials has put it on track to receive expanded conditional approval from the FDA in March 2025, with a final pivotal study still in progress. “Expanded conditional ...
BioSpace25d
Compounders Sue FDA for Declaring Ozempic, Wegovy Shortage Over
The OFA additionally argued that even producers of FDA-approved semaglutide revealed in a recent SEC filing that the “supply constraints’ and ‘drug shortage notifications’ will continue into the ...