FDA grants priority review to Merck’s new biologics license application for V116

V116 is an investigational, 21-valent pneumococcal conjugate vaccine specifically designed to protect adults

Briefs: Aurobindo Pharma and Granules Pharmaceuticals

Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection

FDA and EMA accept Marstacimab regulatory submissions for the treatment of Hemophilia A and B

Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology (ASH) Annual Meeting

Astellas receives USFDA approval for expanded use of Cresemba for treatment of mucormycosis

Cresemba is the only azole antifungal therapy approved for pediatric patients as young as one affected by these serious, potentially life-threatening infections

Zepbound is now available in US for adults living with obesity

Express Scripts to add Zepbound to National Preferred Formulary

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

Dupixent significantly reduced COPD exacerbations in second positive Phase 3 trial

Accelerating FDA submission and confirming potential to become first approved biologic for this serious disease

Evive Biotech and Acrotech Biopharma receive FDA approval of Ryzneuta

FDA approves Merck’s Keytruda plus chemotherapy as first line treatment for locally advanced Metastatic HER2-Negative Gastric

Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone

Pfizer and Astellas' XTANDI approved by USFDA in earlier prostate cancer treatment setting

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