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CDC panel lists reasons to get second COVID booster
One panelist said she was concerned about the potential for “booster fatigue.”
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FDA, DEA pushed to make gabapentin a controlled substance to stop ‘widespread misuse’
There is “substantial evidence of widespread misuse” of gabapentin, plausibly helped by “extraordinary levels of off-label prescribing.”
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Clozapine interrupted: APA, others seek FDA forum on REMS
Clozapine can decrease the neutrophil count, which can lead to severe neutropenia, serious infection, and death.
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High praise, condemnation for CMS Aduhelm coverage plan
The drug clears amyloid in the brain, but that may or may not result in clinical benefit.
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Biden’s FDA chief nominee narrowly wins Senate confirmation
Dr. Robert Califf returns to lead the FDA as the U.S. continues to cope with the pandemic and opioid epidemic.
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Appendectomy or antibiotics? Large trial helps decision-making
The surprise was the lack of an association between appendectomy and factors often presumed to be consistent with more severe appendicitis.
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Medicare intends to limit payment for controversial Alzheimer’s drug
The decision marks something of a shift in Medicare’s approach to paying for medications.
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Study finds sharp drop in opioid scripts among most specialties
A study by the RAND Corp found U.S. clinicians are prescribing fewer opioids, with variation among patients. But the lead author said the report...
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Medicaid implements waivers for some clinical trial coverage
This year, the CMS will help implement a mandate for Medicaid coverage of costs associated with clinical trial participation, a move expected to...
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Califf plans work on opioids, accelerated approvals on return to FDA
In emphasizing the need for continued efforts to address risks of painkillers, Biden’s FDA nominee cites his relatives’ experience in getting 30-...
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Medicare insulin negotiations seen saving $17 billion
Democrats seek to bolster the chances of a law passing that addresses drug prices.
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AMA, hospital group sue federal government over surprise billing law
The rule’s approach to surprise billing would “all but ensure that hospitals, physicians, and other providers will routinely be undercompensated...
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FDA puts clozapine REMS requirements on temporary hold
“We encourage pharmacists and prescribers to continue working with the clozapine REMS to complete certification and patient enrollment,” the FDA...