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image: Conditional FDA Approval for Fatal-Disease Drug

Conditional FDA Approval for Fatal-Disease Drug

By | September 19, 2016

The agency OKs Sarepta Therapeutics’s treatment for Duchenne muscular dystrophy through its accelerated approval pathway, which requires a confirmatory clinical trial.

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Manufacturers have not demonstrated the safety or efficacy of 19 antibacterial agents common in hand and body soaps, according to the US Food and Drug Administration.

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image: Theranos Withdraws Zika Blood Test

Theranos Withdraws Zika Blood Test

By | September 1, 2016

The embattled company failed to include proper safeguards, according to federal regulators.

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image: FDA: Screen All US Blood Donations for Zika

FDA: Screen All US Blood Donations for Zika

By | August 29, 2016

The US Food and Drug Administration recommends that all blood collected across the country be tested for the virus.

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image: Theranos CEO Presents New Device

Theranos CEO Presents New Device

By | August 2, 2016

The troubled firm’s medical conference appearance didn’t deliver the evidence many hoped for.

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image: NYU Halts Studies, Suspends Investigator

NYU Halts Studies, Suspends Investigator

By | June 28, 2016

Experiments conducted at the New York University School of Medicine violated several research standards, according to US Food and Drug Administration investigators.

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The change should allow patients with fatal illnesses easier access to experimental drugs, but gaining permission from drug companies remains the biggest challenge.

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image: Another Fatal-Disease Drug in Limbo

Another Fatal-Disease Drug in Limbo

By | April 26, 2016

A federal advisory panel votes against Sarepta Therapeutics’s treatment for Duchenne muscular dystrophy.

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image: FDA OKs Zika Test for Blood Donations

FDA OKs Zika Test for Blood Donations

By | March 31, 2016

The US Food and Drug Administration approves conditional use of an investigational test for Zika virus.

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image: FDA Head Confirmed

FDA Head Confirmed

By | February 24, 2016

The US Senate approves the Obama administration’s nominee, Robert Califf, as the next commissioner of the Food and Drug Administration.

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