April 30th 2025
AbbVie secures FDA approval for Rinvoq as the first oral Janus kinase inhibitor indicated for giant cell arteritis, expanding its immunology portfolio and signaling strategic growth opportunities in underserved autoimmune markets.
FDA Approves Roche’s Alecensa as Adjuvant Treatment for ALK-Positive Early-Stage NSCLC
April 19th 2024Data from the Phase III ALINA trial show that Alecensa reduced the risk of disease recurrence or death by 76% vs. platinum-based chemotherapy in patients with completely resected IB to IIIA ALK-positive non–small cell lung cancer.
FDA Approves Stelara Biosimilar Selarsdi to Treat Psoriasis, Psoriatic Arthritis
April 17th 2024Alvotech’s and Teva's Selarsdi (ustekinumab-aekn), the second FDA-approved biosimilar to Stelara, is indicated to treat patients aged 6 years and above with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and for patients aged 6 years and above with active psoriatic arthritis.
Enhertu Gets FDA Accelerated Approval for Unresectable, Metastatic HER2-Positive Solid Tumors
April 8th 2024The approval of AstraZeneca’s and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) for adults with unresectable or metastatic HER2-positive solid tumors adds to the drug's approved indications in breast cancer, non-small cell lung cancer, and gastroesophageal junction adenocarcinoma.