FDA pushes back its review decision on Eli Lillys experimental Alzheimers drug donanemab by requiring an advisory committee to discuss the Phase 3 TRA...
Amylyx Pharmaceuticals considers withdrawing its amyotrophic lateral sclerosis drug Relyvrio (sodium phenylbutyrate and taurursodiol) after announcing...
Federal Register notice: FDA revokes an Eli Lilly emergency use authorization for bamlanivimab and etesevimab administered together for treating Covid...
KVK Research and KVK Tech of Bucks County, PA, plead guilty to introducing adulterated drugs into interstate commerce and agree to pay a $1.5 million ...
Novo Nordisk says its experimental weight-loss pill amycretin achieved a 13.1% weight loss in participants in a Phase 1 trial.
FDA grants accelerated approval for BeiGenes Brukinsa used with Genentechs Gazyva to treat some follicular lymphomas.
The Alliance for Regenerative Medicine raises concerns about an FDA draft guidance on alternative manufacturing technologies.
FDA approves Bristol Myers Squibbs Opdivo (nivolumab) for combination use with cisplatin and gemcitabine for first-line treatment of adult patients wi...
