Sun Pharma Announces the Availability of Cosibelimab-ipdl for Advanced Cutaneous Squamous Cell Carcinoma

On January 16, 2026, Sun Pharmaceutical Industries announced that UNLOXCYT™ (cosibelimab-ipdl) is now available in the US for health care professionals to prescribe for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

For more information, read the Sun Pharmaceutical Industries press release.

Posted on 1/16/2026

FDA Approves Amivantamab and Hyaluronidase-lpuj for Subcutaneous Injection

On December 17, the FDA approved amivantamab and hyaluronidase-lpuj for subcutaneous injection for adult patients across all indications approved for the intravenous formulation of amivantamab.

For more information, read the FDA announcement and the Janssen Biotech press release.

Posted on 12/18/2025

FDA Grants Regular Approval to Rucaparib for Metastatic Castration-resistant Prostate Cancer

On December 17, the FDA approved rucaparib for adults with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer previously treated with an androgen receptor-directed therapy. 

For more information, read the FDA announcement and visit the pharmaand website.

Posted on 12/18/2025

FDA Approves Fam-trastuzumab Deruxtecan-nxki With Pertuzumab for Unresectable or Metastatic HER2-positive Breast Cancer

On December 15, the FDA approved fam-trastuzumab deruxtecan-nxki in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test.

For more information, read the FDA announcement and the AstraZeneca press release.

Posted on 12/18/2025

FDA Approves Niraparib and Abiraterone Acetate Plus Prednisone for BRCA2-mutated Metastatic Castration-sensitive Prostate Cancer

On December 12, the FDA approved niraparib and abiraterone acetate with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated metastatic castration-sensitive prostate cancer, as determined by an FDA-approved test.

For more information, read the FDA announcement and visit the Janssen Biotech website.

Posted on 12/12/2025

FDA Approves Lisocabtagene Maraleucel for Relapsed or Refractory Marginal Zone Lymphoma

On December 4, the FDA approved lisocabtagene maraleucel for adults with relapsed or refractory marginal zone lymphoma who have received at least 2 prior lines of systemic therapy.

For more information, read the FDA announcement and the Bristol Myers Squibb press release.

Posted on 12/5/2025

FDA Grants Traditional Approval to Pirtobrutinib for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

On December 3, the FDA granted traditional approval to pirtobrutinib for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have previously been treated with a covalent BTK inhibitor.

For more information, read the FDA announcement and the Lilly press release.

Posted on 12/5/2025

FDA Approves Durvalumab for Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

On November 25, the FDA approved durvalumab with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent durvalumab, for adults with resectable gastric or gastroesophageal junction adenocarcinoma.

For more information, read the FDA announcement and the AstraZeneca press release.

Posted on 11/25/2025

FDA Approves Pembrolizumab With Enfortumab Vedotin-ejfv for Muscle Invasive Bladder Cancer

On November 21, the FDA approved pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph with enfortumab vedotin-ejfv as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer who are ineligible for cisplatin.

For more information, read the FDA announcement and the Merck press release.

Posted on 11/25/2025

FDA Grants Traditional Approval to Tarlatamab-dlle for Extensive Stage Small Cell Lung Cancer

On November 19, the FDA granted traditional approval to tarlatamab-dlle for adults with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.

For more information, read the FDA announcement and the Amgen press release.

Posted on 11/21/2025