FDA

FDA change ushers in cheaper, easier-to-get hearing aids

FDA change ushers in cheaper, easier-to-get hearing aids

It’s now much easier — and cheaper — for many hearing-impaired Americans to get help. Hearing aids can now be sold without a prescription from a specialist. Over-the-counter, or OTC, hearing aids began hitting the market in October at prices that can be thousands of dollars lower than prescription hearing aids. About 30 million people …

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Prescription poo has arrived: FDA approves fecal sludge for unwavering diarrhea

Prescription poo has arrived: FDA approves fecal sludge for unwavering diarrhea

Enlarge / Lab technicians in France prepare stool to treat patients with severe colon infections through fecal microbiota transplantation (FMT), also called gut flora transplantation (GFT) in 2019. For the first time, the United States Food and Drug Administration has granted approval for a fecal-based microbial treatment, which is used to prevent recurrent diarrheal infection …

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FDA plans to move to individual risk-based assessments for blood donors |  CNN

FDA plans to move to individual risk-based assessments for blood donors | CNN

CNN — The U.S. Food and Drug Administration is considering shifting its blood donation policy from general assessments to questionnaires that focus more on individual risk, it said Wednesday. The agency uses data from a donor eligibility study and other blood surveillance information that “will likely support a policy shift to individual risk-based donor screening …

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Vaccinating non-vaxxers is key to ending pandemic: former FDA official

Vaccinating non-vaxxers is key to ending pandemic: former FDA official

Hundreds of Americans die from COVID every day – and the unvaccinated make up the majority of those who died and were hospitalized. That’s according to former FDA deputy chief for vaccines Dr. Phil Krause, who said the government must focus on vaccinating the unvaccinated in order to end the pandemic. “The problem is not …

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FDA approves first treatment to delay onset of type 1 diabetes |  CNN

FDA approves first treatment to delay onset of type 1 diabetes | CNN

CNN — A biologic therapy that delays the onset of type 1 diabetes received approval from the U.S. Food and Drug Administration on Thursday. It is the first therapy approved for the prevention of type 1 diabetes. The monoclonal antibody teplizumab, which will be marketed under the brand name Tzield, from ProventionBio and Sanofi is …

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In turn, FDA adcomm votes in favor of Ardelyx CKD drug despite agency questions

In turn, FDA adcomm votes in favor of Ardelyx CKD drug despite agency questions

After the FDA rejected and questioned Ardelyx’s potential drug for controlling serum phosphorus levels in adults with chronic kidney disease on dialysis, the FDA’s Cardiovascular and Kidney Drug Advisory Committee voted Wednesday 9-4 in favor of the drug as monotherapy, and 10-2 (with one abstention) in favor of the drug when given in combination with …

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