Pharmaceutical Commerce

FDA Approves Novo Nordisk’s Wegovy Pill, Marking First Oral GLP-1 for Weight Management

Novo Nordisk's Wegovy pill is the first oral GLP-1 receptor agonist approved for weight management, offering a new treatment ...
Reuters

Monogram Biosciences timeline reinforced for maraviroc, FDA approval expected midyear - Lazard

Lazard notes that this morning, Pfizer (PFE) announced that its applications for maraviroc would receive accelerated review in the U.S. and Europe. The FDA priority review process takes approx six ...
FiercePharma

Vanrafia, 2nd drug in Novartis' IgAN troika, crosses FDA finish line in payday for Chinook investors

When Novartis bought kidney disease biotech Chinook Therapeutics in 2023 for $3.2 billion upfront, the deal included a conditional payment tied to the timely FDA approval of atrasentan without a ...
Seeking Alpha

Cytokinetics targets aficamten approval with extended PDUFA timeline and growing clinical data

CEO Robert Blum emphasized the company's progress toward the potential commercialization of aficamten, noting the FDA's extension of the PDUFA date to December 26, 2025, to review a submitted REMS ...