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Alexion Pharmas Strensiq OKd for Hypophosphatasia

[ Price : $8.95]

FDA approves an Alexion Pharmaceuticals NDA for Strensiq (asfotase alfa), the first approved treatment for perinatal, infantile an...

Anti-mercury Groups Petition FDA on Dental Amalgam

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Several anti-mercury groups petition FDA to revoke certain sections of its dental amalgam rule so that it conforms to the Minamata...

FDA Approves Iroko Pharmaceuticals NDA for Vivlodex

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FDA approves an Iroko Pharmaceuticals NDA for Vivlodex (meloxicam) capsules, a nonsteroidal anti-inflammatory drug for managing os...

OMB OKs Info on MedWatch

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Federal Register Notice: The Office of Management and Budget approves a collection of information on Medwatch.

OMB OKs Info On Device Labeling Regs

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Federal Register Notice: The Office of Management and Budget approves a collection of information on medical device labeling regul...

Comments Sought on IVD Device Studies Guidance

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Federal Register Notice: FDA seeks comments on a guidance on informed consent for in vitro diagnostic device studies using unident...

Guilty Pleas in Drug Diversion Scheme

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The Justice Department says two men have pleaded guilty as part of an ongoing investigation of a major drug diversion operation.

FDA Approves Merrimack Pancreatic Cancer Drug

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FDA approves a Merrimack Pharmaceuticals NDA for Onivyde (irinotecan liposome injection) for use in combination with fluorouracil ...

Zafgen Closing Beloranib Trials After Patient Death

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Zafgen decides to close the randomized portion of its Phase 3 trial of beloranib in patients with Prader-Willi syndrome after repo...

Guidance on Package Types for Injectable Products

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Federal Register Notice: FDA releases a draft guidance: Selection of the Appropriate Package Type Terms and Recommendations for La...