Amgen, Inc.

The FDA has approved Bayer's Hyrnuo (sevabertinib), an oral tyrosine kinase inhibitor for locally advanced or metastatic non-squamous non-small cell lung cancer in adults with HER2-activating mutations.

The FDA has approved OSVYRTI (denosumab-desu) and JUBEREQ (denosumab-desu), biosimilars to Amgen's Prolia and Xgeva respectively, marking Accord BioPharma's fourth and fifth biosimilar approvals.

The FDA has granted full approval to Amgen's Imdelltra (tarlatamab-dlle) for treating adult patients with extensive stage small cell lung cancer that has progressed after platinum-based chemotherapy.

Oxford-based Scripta Therapeutics emerged from stealth with a $12M seed round to pioneer a biology-first approach to drug discovery targeting transcription factors.

Metagenomi's MGX-001 gene therapy demonstrated curative factor VIII activity in non-human primates, supporting advancement into clinical development for hemophilia A treatment.

Amgen filed three new BPCIA lawsuits in November 2025 against multiple companies developing biosimilars of its blockbuster denosumab products Prolia® and Xgeva®.

Nurix Therapeutics appointed Roger Dansey, M.D., former Chief Development Officer and Chief Oncology Officer of Pfizer Oncology, to its board of directors.

Amgen has filed a second federal lawsuit against Colorado's Prescription Drug Affordability Board, challenging the state's first-in-the-nation price ceiling on arthritis drug Enbrel set at $31,000 per year.

TScan Therapeutics reached alignment with the FDA on a pivotal study design for TSC-101 to treat acute myeloid leukemia and myelodysplastic syndromes, with the trial expected to begin in Q2 2026.

Endo has launched the first and only FDA-approved generic version of RAVICTI (glycerol phenylbutyrate) oral liquid in the United States, providing a new treatment option for patients with urea cycle disorders.