AstraZeneca’s Koselugo recommended for approval in the EU for Neurofibromatosis type 1
The positive opinion is based on results from KOMET, the largest and only placebo-controlled, double-blind global Phase III trial in this patient population
The positive opinion is based on results from KOMET, the largest and only placebo-controlled, double-blind global Phase III trial in this patient population
Tagrisso plus chemotherapy achieves nearly four-year median overall survival in EGFR-mutated advanced lung cancer, setting new global standard in phase III trial
ITP is a disease of complex immune dysregulation leading to low platelet counts, bleeding, and reduced quality of life
Its lead product, Dasynoc, is awaiting FDA approval with a PDUFA date of October 7, 2025
FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC
Longer-term follow up in the FLAURA2 Phase III trial confirms the favourable benefit-risk profile of this combination
LEQSELVI now available for prescription in U.S. nationwide, offering a new option for eligible patients
Masitinib is targeted at patients who are no longer responding to hormone-sensitive prostate cancer treatments
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