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Orphan Drug Designation for Pancreatic Cancer Therapy

[ Price : $8.95]

FDA grants Aduro BioTech an orphan drug designation for CRS-207 for treating pancreatic cancer.

FDA Awards 15 grants for Orphan Drugs

[ Price : $8.95]

FDA awards 15 grants totaling more than $14 million to boost rare disease product development.

FDA Seeks Injunction Against Oregon Supplement Maker

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FDA sues dietary supplement maker James G. Cole seeking a permanent injunction against its alleged promotion and distribution of u...

Specialty Medicine Compounding Pharmacy Recalls Products

[ Price : $8.95]

Specialty Medicine Compounding Pharmacy recalls all lots of unexpired human and veterinary sterile products due to particulate mat...

Indian High Court Probes NCE Drug Study Process

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An Indian Supreme Court order risks delays on 162 drug studies by asking Indian regulators how they approve global clinical trials...

Bard Class 1 Recall of LifeStent Solo Vascular Stent

[ Price : $8.95]

FDA says Bard Peripheral Vascular has begun a Class 1 recall of its LifeStent Solo Vascular Stent due to deployment issues.

CareFusion Class 1 Recall of AVEA Ventilators

[ Price : $8.95]

CareFusion begins a Class 1 recall of its AVEA ventilators because they may experience an under-reporting of tidal volume if used ...

Osiris Therapeutuics Needs BLA to Market Products: CBER

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A CBER untitled letter says Osiris Therapeutics will need a BLA in order to market its amniotic/chorionic-based products.

FDA Denies Petition Seeking Regs or Guidance on Shared REMS

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FDA denies a Prometheus citizen petition request to undertake notice and comment rulemaking to set standards and processes for sin...

FDA Rejects Watson Petition on Rapaflo Bioequivalence

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FDA denies a Watson Labs citizen petition seeking additional bioequivalence requirements for generic applicants seeking approval t...