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.
Bristol Myers Squibb Seeks Approval for Opdivo Regimen in Resectable Non-Small Cell Lung Cancer
February 7th 2024Results from the Phase III CheckMate -77T trial show that Opdivo (nivolumab) plus chemotherapy followed by surgery and adjuvant Opdivo produced statistically significant and clinically meaningful improvements in event-free survival in patients with resectable stage IIA to IIIB non-small cell lung cancer.
FDA Fast Tracks Antibody-Drug Conjugate for Ovarian, Fallopian Tube, Primary Peritoneal Cancers
February 6th 2024BioNTech SE and Duality Biologics' next-generation antibody-drug conjugate is being evaluated for patients with platinum-resistant ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer previously administered one to three systemic treatment regimens.
FDA Approves Takeda's Gammagard Liquid for Chronic Inflammatory Demyelinating Polyneuropathy
January 30th 2024This is Takeda's second approval in chronic inflammatory demyelinating polyneuropathy this month after the FDA approved HyQvia to protect against relapse of neuromuscular disability and impairment in this patient population.
FDA Urges Caution Following Boxed Warning Requirements on CAR T-Cell Therapies
January 25th 2024FDA leadership notes that the overall rate of secondary T-cell cancers among patients administered CAR T-cell therapies appears to be low, even if all reported cases are assumed to be related to treatment.
FDA Issues Complete Response Letter to Theratechnologies sBLA for New Formulation of Tesamorelin
January 25th 2024Theratechnologies said it will address the FDA’s complete response letter and will continue to seek approval for the new formulation of tesamorelin for the treatment of lipodystrophy in patients also diagnosed with HIV.
FDA Issues Complete Response Letter to Astellas for Zolbetuximab BLA for GEJ Adenocarcinoma
January 9th 2024The FDA was unable to approve the Biologics License Application for zolbetuximab because of deficiencies found in a third-party manufacturing facility for the drug, which is under evaluation to treat patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
FDA Grants Priority Review to Pfizer and Genmab's Tivdak for Cervical Cancer Treatment
January 9th 2024Supplemental Biologics License Application would convert the accelerated approval granted to Tivdak (tisotumab vedotin-tftv) to a full approval for patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy.