EU approves Alexion’s Koselugo to treat adults with neurofibromatosis type 1 tumours

Approval based on pivotal KOMET Phase III trial demonstrating significant tumour reduction in adults with NF1

FDA rejects Regeneron’s Eylea HD pre-filled syringe application amid manufacturing setbacks

FDA approves Bayer’s Lynkuet as first hormone-free therapy for menopausal hot flashes

This approval marks a significant milestone in women’s health, introducing Bayer’s first hormone-free treatment for menopause-related symptoms

FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma

The Fast Track Designation was supported by nonclinical data as well as clinical results from the ongoing Phase I/IIa trial evaluating the safety and tolerability

Medherant announces positive Phase 1 results of clinical trial of testosterone patch for women

Medherant’s testosterone TEPI Patch could become the first-in-class testosterone patch developed specifically for women

FDA approves Alembic's Ticagrelor Tablets, 60 mg

Ticagrelor tablets are indicated for reducing the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients

Sanofi's Q3 profit dips marginally as Dupixent sales top €4 billion

The company's net income attributable to equity holders dropped to €2.80 billion from €2.82 billion last year

Biocon Biologics secures Health Canada nod for biosimilars Yesintek, Yesintek IV

Yesintek and Yesintek I.V. are approved for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients

FDA approves Roche’s kidney inflammation drug

Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study

FDA approves Tezspire for chronic rhinosinusitis with nasal polyps

Approval broadens indication for Tezspire to a second disease characterized by epithelial-driven inflammation