GSK’s Exdensur has been approved by the FDA as the first biannual biologic for severe asthma. Find out what this means for patients, payers, and rivals.
AstraZeneca has received European Commission approval for a new subcutaneous formulation of Saphnelo (anifrolumab), allowing adult patients with systemic lupus erythematosus (SLE) to self-administer the drug via a once-weekly pre-filled pen. The regulatory decision follows a positive opinion from the Committee for Medicinal Products for Human Use and is supported by data from the Phase […]
New I-SPY 2 data suggest personalized ctDNA could transform risk stratification in therapy-resistant early breast cancer. Read the full analysis.
OrsoBio’s TLC-6740 combo data hints at a new way to break GLP-1 plateaus. Read what this could change in obesity drug development.
Cosette Pharmaceuticals launches the first generic ciprofloxacin hydrocortisone otic suspension. Find out what this FDA CGT approval really changes.
Sanofi’s $1 billion Alzheimer’s deal with ADEL highlights why tau biology is back in focus and what risks still stand between promise and proof.
Immunome is set to release pivotal Phase 3 varegacestat data in desmoid tumors. Find out what the RINGSIDE results could change for the field.
Milestone Pharmaceuticals’ CARDAMYST FDA approval marks a new era in PSVT care. Find out how this first‑in‑class nasal treatment could transform acute arrhythmia management.
Vaxxas Pty Ltd, the Australian biotechnology company known for its high-density microarray patch (HD-MAP) platform, has secured a manufacturing licence from the Therapeutic Goods Administration (TGA) to produce its investigational vaccine delivery system under Good Manufacturing Practice (GMP) conditions. The licence, granted for its Brisbane-based biomedical facility, clears a critical regulatory hurdle and allows Vaxxas […]
Avenzo shares Phase 1 data on CDK2 inhibitor AVZO-021 in HR+/HER2- breast cancer. Find out what it means for post-CDK4/6 resistance strategies in 2025.