FDA

Amylin analogs could well match the weight loss seen with Novo Nordisk and Eli Lilly’s GLP-1-based blockbusters with less fewer tolerability issues. The Danish company believes petrelintide will lead the pack and is vetting potential big pharma partners very carefully.

Alvotech has followed its European filing for a biosimilar to Regeneron’s Eylea (aflibercept) 2mg with acceptance for review from the US Food and Drug Administration for its AVT06 candidate.

Argenx has discontinued Vyvgart for the rare skin disease as other potential candidates linger in the very early stages of development.

Jim Jones, the head of the FDA's food programs, resigned due to widespread layoffs at the agency imposed by the Trump administration’s Department of Government Efficiency.

As many as 700 employees reportedly dismissed from posts starting on 14 February as the culling of the federal workforce by the Trump administration’s Department of Government Efficiency reaches FDA.

Jim Jones resigna due to widespread layoffs at the agency the Trump administration’s Department of Government Efficiency imposed.

"While we mourn his passing, we also celebrate his remarkable legacy, which will continue to shape AHPA and the broader industry for years to come,” AHPA says.

The Swedish biotech has held positive talks with US regulators about the Phase III design for its pancreatic cancer candidate, mitazalimab. Now it needs to pin down a partner.

A month after Vanda failed to win a trade secrets case against the US FDA corresponding to generic approvals for its brands Hetlioz and Fanapt, the originator has again fallen, this time to the agency and Teva in the alleged unlawful approval of the Israeli firm’s generic Hetlioz product.

Sanofi has bolstered its insulin offerings by bagging the first US FDA approval for a rapid-acting insulin aspart biosimilar, leaving several would-be sponsors in its wake.