USFDA accepts sBLA of TIVDAK for priority review for patients with metastatic cervical cancer

Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy

European Commission approves Pfizer’s Talzenna in combination with Xtandi for treatment of metastatic castration-resistant prostate cancer

TALZENNA is the first and only PARP inhibitor approved in combination with standard of care XTANDI for mCRPC patients in the European Union

Jiangsu Vcare files NDA for Vicagrel Capsules with USFDA

Roche receives USFDA’s priority review to Xolair for food allergies based on positive NIH Phase III study results

If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure

Bristol Myers Squibb to buy Karuna Therapeutics for US$ 14 billion

Transaction delivers KarXT, a first-in-class M1/ M4 muscarinic receptor agonist with differentiated efficacy and safety

USFDA grants priority review for Patritumab Deruxtecan in US for certain patients with EGFR-mutated non-small cell lung cancer

If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients

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