AbbVie’s (NYSE:ABBV) new drug application for its Parkinson’s disease combination therapy has been denied approval by the FDA. In a complete response letter sent to the drugmaker, the U.S. drug regulator cited observations that were identified during inspection of a third-party manufacturer listed in the application. The inspection at theContinue Reading
Waldemarus/iStock via Getty Images Argenx (NASDAQ:ARGX) has received FDA approval for Vyvgart Hytrulo for the treatment of adults with chronic inflammatory demyelinating polyneuropathy, or CIDP. The Dutch biotech company said the product was the first and only neonatal Fc receptor blocker approved to treat the condition. Vyvgart Hytrulo is alsoContinue Reading
JasonDoiy The U.S. has granted approval to Roche (OTCQX:RHHBY)-owned Genentech’s biologic crovalimab to treat the rare condition paroxysmal nocturnal hemoglobinuria. The application was supported by two phase 3 trials, one of which demonstrated that crovalimab achieved disease control and was well-tolerated while the other showed a consistent benefit-risk for theContinue Reading
