Court finds US FDA did not impede Catalyst orphan exclusivity for Firdapse as it approved different indication for competing product. Biogen loses 10-year patent battle against competing multiple sclerosis drug makers.

As agency observers wonder whether and how political considerations will impact the timing of a COVID-19 vaccine approval or authorization, the Pink Sheet looks at instances through the years where agency staffers found themselves operating under precedents with which they disagreed or that didn’t work out as expected.

Regulators in the US have approved Gavreto for metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer, setting the stage for a head-to-head battle for market share with Eli Lilly's Retevmo.

Relay raises $400m to kick off July’s second big week of US initial public offerings. Also, Ocumension and Immunotech launch Hong Kong IPOs, Amgen invests $421m in BeiGene’s $2.08bn offering, Cytokinetics gets up to $400m in deal and investment funding, and Imvax closes $111m series C round.