Keyword: Fresenius Kabi

The FDA issued a 22-page, 11-observation Form 483 to Akorn’s Parsippany, New Jersey, plant following a five-week inspection.

In a Humira patent deal with AbbVie, Fresenius Kabi will have to pay undisclosed royalties and can launch its biosim in Europe upon approval.

Fresenius continues to hammer Akorn with fraud allegations as the company tries to extract itself from a $4.3 billion buyout of the injectables maker.

Fresenius’ $4.3 billion buyout of generics maker Akorn is in jeopardy as they investigate allegations that Akorn violated FDA drug development standards.

The FDA has decided that Fresenius Kabi’s retrieval of more than 200,000 syringes rises to the level of a Class I recall.

With plans for a major expansion of its site North Carolina, Fresenius Kabi's investments aimed mainly at the U.S. generics market now top $5 billion.

An Akorn sterile drug plant is in hot water with the FDA again, but it may be a problem for Fresenius Kabi, which is buying the generics manufacturer.

Fresenius Kabi, which has been spending heavily to broaden its capabilities, has started construction on a $250 million project in Illinois.

With a patent loss looming, Takeda filed a citizen petition pushing the FDA to knock back generic Velcade competition.

Fresenius’ new CEO has pulled off a dealmaking double play, committing more than $5.4 billion to expand its reach in both sterile generics and in biosimilars.