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image: FDA Calls for Data on ALS Drug

FDA Calls for Data on ALS Drug

By | April 21, 2015

In the midst of a debate about an experimental drug’s early approval, the US Food and Drug Administration requests that full trial results be released.

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image: ALS Drug Access Debated

ALS Drug Access Debated

By | April 7, 2015

Biotech company Genervon has requested accelerated approval for its experimental ALS drug after a small but promising Phase 2 trial. Patients advocate for its acceptance, while researchers urge caution.

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image: FDA Deems GM Apples, Potatoes Safe

FDA Deems GM Apples, Potatoes Safe

By | March 23, 2015

Genetically modified, non-browning apples and bruise-resistant potatoes are safe, the US Food and Drug Administration says.

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image: FDA OKs First Biosimilar

FDA OKs First Biosimilar

By | March 6, 2015

The US Food and Drug Administration approves Sandoz’s Zarxio, a biosimilar to Amgen’s filgrastim, which is mainly prescribed for cancer patients.

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image: HHS Rolls Out Public Access Plans

HHS Rolls Out Public Access Plans

By | March 3, 2015

The US Department of Health and Human Services outlines how the National Institutes of Health and its other agencies will make research results public.

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image: Capsule Reviews

Capsule Reviews

By | March 1, 2015

Evolving Ourselves, The Man Who Touched His Own Heart, Bats, and The Invaders

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image: FDA OKs 23andMe Test

FDA OKs 23andMe Test

By | February 20, 2015

The US Food and Drug Administration will allow the personal genomics company to resume a disease-risk analysis.

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image: Clinic Trial Problems Kept Mum

Clinic Trial Problems Kept Mum

By | February 11, 2015

Despite documented dysfunction in a number of studies, rarely do those problems get a mention in the resulting publications, according to a new study.

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image: FDA Head Leaving Post

FDA Head Leaving Post

By | February 6, 2015

US Food and Drug Administration commissioner Margaret Hamburg is stepping down after six years on the job.

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image: Lazarus Drugs

Lazarus Drugs

By | February 1, 2015

While some drugs sail through development, others suffer setbacks, including FDA rejections, before reaching the market.  

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