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A new International Conference on Harmonization guidance provides further clarification for sponsors conducting clinical evaluatio...[ Price : $8.95]
FDA extends by three months its review of an Impax Pharmaceuticals NDA for Rytary (carbidopa-levodopa) for treating idiopathic Par...[ Price : $8.95]
FDA approves a Genentech BLA supplement to expand approval for Actemra (tocilizumab) for treating adults with moderately to severe...[ Price : $8.95]
CDER says two Tarceva (erlotinib) sales aid are misleading because they contain misleading efficacy claims, minimize the risks, an...[ Price : $8.95]
Genzyme presents Phase 3 data for a 14 mg dose of its oral drug Aubagio showing that it significantly reduced the annualized relap...[ Price : $8.95]
FDA approves a Celgene Corp. sNDA for Abraxane for the first-line treatement of locally advanced or metastatic non-small cell lung...[ Price : $8.95]
FDA says it needs a new regulatory scheme to deal with large scale compounding operations like New England Compounding Center, whi...[ Price : $8.95]
Federal Register Notice: FDAs Risk Communication Advisory Committee will meet 11/2 to discuss issues such as avoiding message fati...