Food and Drug Administration, Safety, Sales and Side effects

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FDA approves first Stelara biosimilar, Wezlana

European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). Like Stelara, the most serious known side effect of Wezlana is infection. US sales of Stelara totalled $6.4

Food and Drug Administration

Food and Drug Administration FDA Side effects Safety

Interview: Dr Alan S Louie – US Food and Drug Administration Delays

Pharmaceutical Technology

AUGUST 17, 2008

Nicola Boyes: The FDA has come under criticism recently for extreme delays in approving new drugs for the market, is the criticism valid and if so how are the delays impacting on the US pharmaceutical industry at present? This higher threshold, although not explicit, would also be expected to slow drug approvals.

Food and Drug Administration

Food and Drug Administration Food FDA Safety

Pharma Rep Focus

FDA approves first Stelara biosimilar, Wezlana

Interview: Dr Alan S Louie – US Food and Drug Administration Delays

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