Pink SheetMSN Laboratories’ US Food and Drug Administration approval for its generic version of Novartis’ multi-billion-dollar heart failure drug Entresto (sacubitril/valsartan) has been stayed for now by a Wa
Pink SheetNovartis AG has swiftly filed suit against the US Food and Drug Administration after the agency’s denial of a second citizen petition opened the door for what the Swiss originator company claims is a
Generics BulletinUS suitability petitions may be seeing renewed interest from sponsors following a surge of filings after the introduction of goal dates in October and then a drop-off of submissions after that. Nimish
ScripGoal dates and enhanced regulatory review processes appear to have invigorated sponsors, including leading Indian pharma firms, to file or refile suitability petitions in the US, reviving a strategic