The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end ...
Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory decisions.
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved ALYFTREK (vanzacaftor/tezacaftor ...
The medicine hit its primary endpoint of a decrease in the average daily leg pain intensity as measured by the Numeric Pain ...
Vertex Pharmaceuticals offers promising opportunities in pain management, cystic fibrosis treatments, and a diversified ...
Novo Nordisk got the go-ahead for its once-daily prophylactic haemophilia therapy Alhemo (concizumab) at its second attempt, having been turned down by the US regulator last year. The tissue ...
The early approval of vanza triple, or Alyftrek, is “positive, but was largely expected,” adds the analyst, who sees upside from pipeline updates in 2025. Published first on TheFly – the ul ...