Bristol Myers Squibb and Ono Pharmaceutical are suing Amgen over seven patents tied to its proposed Opdivo biosimilar ABP 206, opening an important legal battle around a cancer drug that generated more than $10 billion in 2025.
Arlocabtagene autoleucel met response and complete-response endpoints in patients already exposed to immunomodulators, proteasome inhibitors, anti-CD38 treatment and BCMA therapy, positioning GPRC5D as a possible next CAR T target after increasingly crowded myeloma treatment sequences.
Milvexian failed to reduce cardiovascular death, heart attack or ischemic stroke after acute coronary syndrome in the Phase 3 LIBREXIA ACS trial, although the drug did not increase intracranial or fatal bleeding, leaving two major Phase 3 programs to determine whether factor XIa inhibition still works in other diseases.
Bristol Myers Squibb has secured accelerated approval from the United States Food and Drug Administration for Zenbexus, making iberdomide the first therapy from the company’s CELMoD class to reach the US market. The oral drug was approved as part of a three-drug regimen with subcutaneous daratumumab and hyaluronidase-fihj plus dexamethasone for adults with multiple myeloma
Replimune Group is awaiting a delayed FDA decision on RP1 after advisers voted that its melanoma results were clinically meaningful. Approval would create a more accessible oncolytic immunotherapy option, but regulators remain divided over whether the single-arm IGNYTE trial reliably proves RP1’s contribution.
The United States Food and Drug Administration (FDA) has granted accelerated approval to Replimune Group’s Tudriqev in combination with nivolumab for adults with unresectable advanced cutaneous melanoma that progressed during a programmed death receptor-1 blocking treatment. The August 6, 2026 decision gives oncologists a new option for a difficult stage of melanoma treatment, when tumours
A United States Food and Drug Administration (FDA) advisory committee has voted 10 to 3 that efficacy findings from Replimune Group’s IGNYTE study of RP1 plus nivolumab are evaluable and clinically meaningful, handing the experimental melanoma treatment a significant regulatory reprieve after two earlier rejection letters. The committee considered RP1, also known as vusolimogene oderparepvec,
Harbour BioMed expects up to $67 million interim profit as antibody deals lift revenue, but margin trends will shape the next investor debate.
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