Topic
Fda Approval
5 stories about Fda Approval that passed the news check, newest first.
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FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer
On September 9, 2025, the FDA approved the gemcitabine intravesical system, marketed as Inlexzo by Janssen Biotech, Inc.
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FDA approves amivantamab-vmjw with carboplatin and pemetrexed for non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations
On September 19, 2024, the FDA approved amivantamab-vmjw (Rybrevant, Janssen Biotech) with carboplatin and pemetrexed.
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FDA approves axatilimab-csfr for chronic graft-versus-host disease
On August 14, 2024, the FDA approved axatilimab-csfr (Niktimvo, Incyte Corporation) for chronic graft-versus-host disease (cGVHD).
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FDA approves ensartinib for ALK-positive locally advanced or metastatic non-small cell lung cancer
On December 18, 2024, the FDA approved ensartinib (brand name Ensacove, from Xcovery Holdings, Inc.).
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FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer
On October 10, 2024, the FDA approved inavolisib (Itovebi, Genentech) with palbociclib and fulvestrant.
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