Drugs@FDA · Oct 22, 2025
FDA expands Vyepti (eptinezumab-jjmr) approval
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Lundbeck Seattle Biopharmaceuticals, Inc.
Drugs & FDA · page 8
Drug approvals, label changes, and FDA drug news.
Drugs@FDA · Oct 2, 2025
FDA expands Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) approval
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Genentech Inc
Drugs@FDA · Oct 2, 2025
FDA expands Tecentriq (atezolizumab) approval
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Genentech Inc
Drugs@FDA · Sep 26, 2025
FDA expands Tremfya (guselkumab) approval
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Janssen Biotech
Drugs@FDA · Sep 26, 2025
FDA expands Tremfya (guselkumab) approval
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Janssen Biotech
Drugs@FDA · Sep 19, 2025
FDA expands Tremfya (guselkumab) approval
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Janssen Biotech
Drugs@FDA · Sep 10, 2025
FDA expands Koselugo (selumetinib sulfate) approval
Efficacy supplement (new or revised indication). capsule, oral. Sponsor: Astrazeneca
Drugs@FDA · Sep 10, 2025
FDA approves Koselugo (selumetinib)
Original new drug approval. capsule, oral. Sponsor: Astrazeneca
Drugs@FDA · Aug 18, 2025
FDA expands Vyepti (eptinezumab-jjmr) approval
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Lundbeck Seattle Biopharmaceuticals, Inc.
Drugs@FDA · Aug 5, 2025
FDA expands Ajovy (fremanezumab-vfrm) approval
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Teva Pharms Usa
Drugs@FDA · Jul 30, 2025
FDA expands Biktarvy (bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate) approval
Efficacy supplement (new or revised indication). tablet, oral. Sponsor: Gilead Sciences Inc
NCI Cancer Currents · May 2, 2025
FDA Approval Likely to Change Initial Treatment for Some People with Advanced Colorectal Cancer
FDA has approved the combination of the immunotherapy drugs ipilimumab (Yervoy) and nivolumab (Opdivo) for the initial treatment of people with advanced colorectal cancer whose tumors are classified as MSI-H or dMMR.