Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH
Late-stage Fabhalta development program ongoing in multiple complement-mediated conditions
Late-stage Fabhalta development program ongoing in multiple complement-mediated conditions
Accelerating FDA submission and confirming potential to become first approved biologic for this serious disease
Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone
XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy in nonmetastatic castration-sensitive prostate cancer
Likmez oral suspension is the first and only FDA-approved liquid option for patients with adherence hurdles such as dysphagia, difficulty swallowing
In 2022, darolutamide was FDA-approved in combination with docetaxel chemotherapy for adults with metastatic hormone-sensitive prostate cancer
The companies plan to start a pivotal Phase 3 trial in the coming months
Orgovyx is the first and only oral GnRH receptor antagonist approved for advanced prostate cancer in Canada
The vaccine further advances Pfizer’s vaccine portfolio and builds on more than 20 years of expertise and knowledge in the prevention of meningococcal disease
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