The latest news from the global pharmaceutical industry
Eisai and Biogen have announced that Leqembi (lecanemab) has been launched in China as a treatment for mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia, following its approval in January 2024.
Eli Lilly has announced that it will donate $6.5m to the United States Fund for UNICEF in order to expand UNICEF's work to ‘improve the health outcomes of millions of children and youth at risk of noncommunicable diseases (NCDs) living in resource-limited settings in India’, according to the press release.
The FDA has granted an expanded orphan drug designation (ODD) for brain cancer immunotherapy survaxm, originally created at Roswell Park Comprehensive Cancer Center.
Merck has announced that the FDA has approved capvaxive (pneumococcal 21-valent conjugate vaccine).
Eli Lilly has announced that the FDA has approved Kisunla (donanemab-azbt, 350mg/20ml once-monthly injection for iv infusion) for the treatment of adult patients with early symptomatic Alzheimer’s disease (AD).
AbbVie has announced that the FDA has approved Skyrizi (risankizumab-rzaa) for the treatment of adult patients with moderately-to-severely active ulcerative colitis (UC) and moderate to severe crohn’s disease.
Sarepta Therapeutics has announced that the FDA has approved an expansion to the labelled indication for Elevidys (delandistrogene moxapar vovec-rokl) to include individuals with DMD with a confirmed mutation in the DMD gene who are at least four years of age.
Pfizer has announced that the FDA has approved Beqvez (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate-to-severe haemophilia B.
Roche has announced that the FDA has approved its human papillomavirus (HPV) self-collection solution.
Amgen has announced that the FDA has approved Imdelltra (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer who have had disease progression on or after platinum-based chemotherapy.
Eko Health has announced that the FDA has approved its low ejection fraction (low ef) detection artificial intelligence (AI).
AstraZeneca and Daiichi Sankyo have announced that their biologics license application (bla) for datopotamab deruxtecan (dato-dxd) has been accepted in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (hr)-positive, her2-negative breast cancer who have had prior systemic therapy for unresectable or metastatic disease.