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Panel Backs Descovy for Preventing HIV in Men

[ Price : $8.95]

An FDA advisory committee has voted 16-2 to recommend approval for Gilead Sciences HIV drug Descovy for pre-exposure prophylaxis (...

Draft Guide on Fabry Disease Drug Development

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Federal Register notice: FDA makes available a draft guidance on Fabry Disease drug development.

Evoke to Resubmit Gimoti NDA

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Evoke Pharma says it will resubmit its NDA for Gimoti nasal spray to FDA by the end of this year.

Dynacure Gets Orphan Status for DYN101

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FDA grants Dynacure an orphan drug designation for DYN101, an investigational antisense medicine for treating centronuclear myopat...

Boston Scientific to Divest Some Assets

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The Federal Trade Commission says Boston Scientific has agreed to divest two product lines to resolve antitrust concerns about its...

Transactional Science Role for NIH: Woodcock

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CDER director Janet Woodcock urges the National Institutes of Health to take on research into translational science that can help ...

FDA OKs Helix L-DOS47 Study in Pancreatic Cancer

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FDA authorizes a Helix BioPharma IND to begin a Phase 1b/2 study of L-DOS47 and doxorubicin in patients with advanced metastatic p...

Erroneous Adverse Event Report Doesnt Stop Study: Sarepta

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Sarepta says an erroneous adverse event report in a study of a Duchenne muscular dystrophy gene therapy candidate did not interrup...

Info Collection on IVD Study Informed Consent

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Federal Register notice: FDA sends to OMB an information collection extension for its guidance on informed consent for in vitro di...

Annual Report on Postmarketing Requirements

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Federal Register notice: FDA makes available an annual report entitled Report on the Performance of Drug and Biologics Firms in Co...