Industry News

Novartis announced that oral Fabhalta iptacopan has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G), to reduce proteinuria, making it the first and only treatment approved for this condition.

Zydus Life sciences Limited has received final approval from the United States Food and Drug Administration USFDA to manufacture Apalutamide Tablets, 60 mg.

The product is being recalled because the infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg 100 mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.

Alkem Laboratories Ltd launches of generic empagliflozin and its combinations in India under the brand name Empanorm

Venus Remedies Ltd, a leading Indian pharmaceutical company renowned for its longstanding expertise in combatting antimicrobial resistance (AMR), announced that it has entered into an exclusive license agreement with Infex Therapeutics, a UK-based anti-infectives specialist for the clinical development of MET-X.

A new vaccine that boosts immunity against tuberculosis has been shown to be effective in pioneering pre-clinical trials, as part of a successful collaboration between three leading Australian research institutions. A study into the vaccine’s effectiveness, published in eBioMedicine, was led by experts from the Sydney Infectious Diseases Institute at University of Sydney, the Centenary Institute and the Monash Institute of Pharmaceutical Science at Monash University.

Galderma today announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency and Swissmedic have granted the marketing authorization of nemolizumab for the treatment of both atopic dermatitis and prurigo nodularis in the UK and Switzerland, respectively. Specifically, the approvals are for nemolizumabs subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors