Heron Therapeutics, Inc.

Major amendments containing new clinical trial data or analyses are driving the high usage of three-month extensions to PDUFA goal dates over the past year, an analysis of the Pink Sheet ’s US FDA Pe

UroGen Pharma, Ltd. anticipated filing for US Food and Drug Administration approval in 2024 for UGN-102 in the treatment of low-grade, intermediate-risk, non-muscle invasive bladder cancer (LG-IR-NMI

Vertex is continuing to ride high thanks to its near-monopoly in cystic fibrosis disease-modifying treatment, led by blockbuster Trikafta (elexacaftor/tezacaftor/ivacaftor). The oral therapy earned $

Companies that are developing local anesthetic products intended to have a long-acting effect should collect trial data on “clinically meaningful outcomes,” such as reduction in hospitalization, even