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Human Genome Sciences and Novartis Scrap Zalbin

[ Price : $8.95]

Human Genome Sciences and its development partner, Novartis, decide not to further develop Zalbin (albinterferon alfa-2b) after re...

FDA May Go After Internet Pharmacy Domain Names

[ Price : $8.95]

A Domain Incite report says FDA may be preparing to take stronger action to shut down Internet domain names of pharmacies illegall...

FDA 'Orphan Status' for Prolor Growth Hormone

[ Price : $8.95]

FDA grants Prolor Biotech an orphan drug designation for hGH-CTP, a long-acting human growth hormone.

Aeterna Zentaris Granted 'Orphan' Status for Hormone Deficiency Test

[ Price : $8.95]

FDA grants Aeterna Zentaris an orphan drug designation for Solorel (macimorelin) and its use as an oral diagnostic test for adult ...

CDRH Considering Developing 42 Guidances in 2011

[ Price : $8.95]

CDRH publishes for comment a list of 42 guidances it is considering developing in 2011.

Consolidate CMC Guidances: BIO

[ Price : $8.95]

Industry commenters on an FDA draft guidance on reportable post-manufacturing changes say FDA should consolidate its CMC reporting...

Watson Labs ANDA for Generic Azilect

[ Price : $8.95]

Watson Laboratories files an ANDA for rasagiline mesylate 0.5 and 1.0 mg tablets, a generic copy of Teva Neuroscience's Azilect ta...

Actelion Not Following PADE Reporting Requirements

[ Price : $8.95]

FDAs San Francisco District Office warns Actelion that it is violating regulations by not promptly reporting deaths in patients ta...

FDA Accepting Applications for Pan American Health Agreement

[ Price : $8.95]

Federal Register Notice: FDA plans to accept an application to award a cooperative agreement to the Pan American Health Organizati...

Azdone Not Withdrawn for S&E

[ Price : $8.95]

Federal Register Notice: FDA determines that Azdone tablet, 5mg/500mg was not withdrawn for reasons of safety or effectiveness.