Topic
FDA
6 stories about FDA that passed the news check, newest first.
Launch ·
FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer
On December 12, 2025, the FDA approved niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.) with prednisone.
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FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer
On April 18, 2024, the FDA approved alectinib (Alecensa, Genentech) as adjuvant treatment following tumor resection.
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FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection
The FDA approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech) for subcutaneous injection.
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FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinoma
On December 13, 2024, the FDA approved cosibelimab-ipdl (Unloxcyt) from Checkpoint Therapeutics.
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FDA approves durvalumab for limited-stage small cell lung cancer
On December 4, 2024, the FDA approved durvalumab (Imfinzi, AstraZeneca) for limited-stage small cell lung cancer.
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FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma
The FDA approved erdafitinib (Balversa, Janssen Biotech) on January 19, 2024.
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