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image: Drug Approval Timeline Same as 20 Years Ago

Drug Approval Timeline Same as 20 Years Ago

By Kerry Grens | January 9, 2017

A report finds that new medications still take about 12 years to go from patent to patient.

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image: FDA Approves First Treatment for Spinal Muscular Atrophy

FDA Approves First Treatment for Spinal Muscular Atrophy

By Ben Andrew Henry | December 28, 2016

The oligonucleotide therapeutic will soon be available in the U.S.

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image: FDA OKs Clinical Trials of Ecstasy for PTSD

FDA OKs Clinical Trials of Ecstasy for PTSD

By Joshua A. Krisch | December 1, 2016

The illicit drug has shown promise in helping people with debilitating post-traumatic stress disorder.

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image: Biomedical Research Bill Approved in House

Biomedical Research Bill Approved in House

By Ben Andrew Henry | December 1, 2016

The 21st Century Cures Act could provide funds to federal research agencies for the decade and accelerate the drug approval process.

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image: Trump Announces HHS, CMS Picks

Trump Announces HHS, CMS Picks

By Joshua A. Krisch | November 30, 2016

President-elect Donald Trump chooses Representative Tom Price to lead the Department of Health and Human Services, Seema Verma to lead the Centers for Medicare and Medicaid Services.

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An early-stage study of the effectiveness of a lung-cancer vaccine developed by scientists in Cuba could start as early as next month.

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image: Q&A: From FDA to Industry

Q&A: From FDA to Industry

By Kerry Grens | September 27, 2016

Among a subset of US Food and Drug Administration regulators who leave the agency, more than half go to work for pharmaceutical companies, researchers report.

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image: Feds Demand More Clinical Trial Reporting

Feds Demand More Clinical Trial Reporting

By Kerry Grens | September 19, 2016

Expanded US Health and Human Services rules will require the results of more human studies to be made public.

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image: Conditional FDA Approval for Fatal-Disease Drug

Conditional FDA Approval for Fatal-Disease Drug

By Tracy Vence | 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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