Alnylam Wins FDA Approval For Givlaari, Its Second RNAi Drug

Givosiran was approved by the US FDA for the treatment of acute hepatic porphyria, a rare generic blood disorder, nearly three months ahead of the action date.

approved label. approved blue band sign. approved. approved stamp on white background - Vector — Alnylam's Givlaari is the first drug approved for AHP

Alnylam Pharmaceuticals Inc. is on its way to becoming a multi-product drug maker, having secured approval for a second RNAi-based therapeutic from the US Food and Drug Administration. That means the company is poised to meet the goal of having multiple commercial products before 2020 previously set by CEO John Maraganore.

"We believe the FDA's approval of Givlaari further establishes RNAi therapeutics as a whole new class of medicines, which has the potential to deliver significant impact to patients across diseases, both

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Industry Leaders Grapple With Trump’s MFN Pricing Plan

14 May 2025

• By Jessica Merrill

At the Bank of America health care conference, pharma leaders speculated on what Trump’s executive order on drug pricing could mean for US and European drug prices.