Government

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FDA approves sBLA for Genentech's Gazyva

Genentech last week announced that the Food and Drug Administration approved a supplemental biologics license application for Gazyva to be used in combination with chlorambucil chemotherapy in people with previously untreated chronic lymphocytic leukemia.

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FDA approves Xtoro from Alcon Labs

The Food and Drug Administration on Wednesday approved Xtoro (finafloxacin otic suspension), a new drug that's used to treat acute otitis externa, commonly known as swimmer's ear. 

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Signifor from Novartis approved by FDA

Novartis on Tuesday received approval from the Food and Drug Administration for Signifor long-acting release (pasireotide) for injectable suspension, for intramuscular use. 

 

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FDA reform could be key to lowering costs

After a recent spike in the prices charged for some generic drugs led to outcries from pharmacists, patient advocates and federal lawmakers, a report issued last month suggests that drug costs can be controlled if the Food and Drug Administration changes the way it handles reviews and approvals.