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Latest Headlines

CSL nets closeout letter after FDA violations

After more than two years of manufacturing problems, CSL Biotherapies cleaned up its act, receiving a closeout letter from the FDA.

CSL, whose vaccine was tied to convulsions, gets FDA closeout letter

Australian vaccinemaker CSL Biotherapies, which landed in a boatload of trouble with the FDA and Australian authorities after children taking one of its vaccines began convulsing, has apparently satisfied U.S. regulators that its manufacturing is sound, netting a closeout letter as confirmation.

CSL flu shot fits linked to viral components

The company attributed the problem to the levels of virus components in the end product and said the increased levels of fits must be related to characteristics of the virus unique to the 2010 strain.

UPDATED: CSL confirms convulsions appear tied to Fluvax

In a warning letter two years ago, the FDA told Australian vaccine maker CSL that it should have thoroughly investigated whether its manufacturing processes had something to do with children having seizures after getting its Fluvax vaccine. The company on Thursday said a two-year study appears to confirm that suspicion.

CSL confirms Fluvax manufacturing tied to convulsions in children

A CSL executive said Thursday that the study found its manufacturing left excessive viral components in the drug, triggering convulsions in some children, Bloomberg reports.