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The FDA had been expected to decide by next week, but a back-and-forth between state and federal officials about details of the proposal means the wait will continue, a court document says.
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A Tampa-area mom couldn't watch her 9-year-old's leukemia go untreated. She started campaigning to fix a broken system and get patients the treatments they need in the face of drug shortages.
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The point isn’t that Donald Trump managed drug shortages badly as president or that Joe Biden is handling them badly now, experts said. Many factors contribute to the problem.
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A federal audit found lax oversight and multiple cases of child welfare workers failing to follow state regulations on psychotropic or opioid medication.
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The agency reiterated its longstanding position that a lone study by drugmaker Brainstorm doesn't provide convincing evidence that its stem cell-based therapy helps patients with amyotrophic lateral sclerosis.
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Thousands of patients with autoimmune diseases who rely on Humira, with a list price of $6,600 a month, could get financial relief from new low-cost rivals. So far, the pharmacy benefit managers that control drug prices have not delivered on those savings.
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The Biden administration unveiled the first 10 drugs subject to price negotiations, taking a swipe at the pharmaceutical industry. But what does it mean for patients?
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The government will negotiate new prices for the commonly prescribed drugs, but the cuts won't take effect until 2026. In the meantime, drug-makers are fighting the negotiations with lawsuits.
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Brand-name drug prices in the U.S. — more than three times the price in other developed countries — are related neither to the amount of research and development nor their therapeutic value, research shows.
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The state alleges the federal agency violated the Freedom of Information Act. The revised lawsuit includes allegations that the FDA did not properly respond to a records request submitted in May.