FDA Accepts sBLA for Priority Review of Dupilumab for Uncontrolled COPD
The FDA’s decision is planned for June 2024, and follows the successful results of the BOREAS and NOTUS trials.
Source: hcplive.com
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RESPONSE: Seladelpar Normalizes Alkaline Phosphatase, Reduces Pruritus in PBC
Results from the phase 3 trial showed seladelpar elicited biochemical response, normalized alkaline phosphatase, and reduced pruritus at a greater rate than placebo.
Source: hcplive.com
Robert Wood, MD: Impact of Omalizumab Approval on Management of Pediatric Food Allergy
Robert Wood, MD, discusses how the FDA approval of omalizumab (Xolair) changes the management of pediatric food allergy and what type of hurdles to optimal uptake the community may encounter.
Source: hcplive.com
FDA to Speed Up Review of Krazati Combo for Metastatic CRC
The Food and Drug Administration granted a priority review to Krazati plus Erbitux for KRAS G12C-mutant locally advanced or metastatic colorectal cancer.
Source: curetoday.com
Adagrasib Plus Cetuximab Under Review for KRASG12C-Mutated Advanced Colorectal CA
The application is supported by data from the multicohort phase 2 KRYSTAL-1 study, which evaluated adagrasib in heavily pretreated patients with KRASG12C-mutated advanced CRC.
Source: empr.com