Keeping Track: US FDA Approves Korsuva, Skytrofa And Comirnaty, But Tecentriq Loses TNBC Indication
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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The Swiss group has delivered on its promise to secure more deals in the nephrology space by bagging the rights in Europe, Australia and New Zealand to sparsentan, which is deep into a Phase III program for focal segmental glomerulosclerosis and IgA nephropathy.
US FDA showed some regulatory flexibility by relying on longer-term follow-up from Merck’s original single-arm trial, rather than additional confirmatory studies, to retain the first-line claim, but it narrowed the target population to those with the greatest unmet need; Keytruda indication was one of six 'dangling' accelerated approvals re-examined by Oncologic Drugs Advisory Committee in April.
Departures of Marion Gruber and Philip Krause may stem from White House and CDC actions related to the COVID-19 vaccines.