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FDA Approvals Summary - July 2025
FDA Drug Approvals
FDA approved several new drugs in July 2025, including treatments for phenylketonuria, chronic hand eczema, hereditary angioedema, EGFR-mutated lung cancer, and relapsed multiple myeloma, offering new hope for patients.
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First Global DPP1 Inhibitor Approved by FDA
FDA
The FDA has approved brensocatib, the world’s first DPP1 inhibitor, for treating non-cystic fibrosis bronchiectasis in patients aged 12+, marking a breakthrough in targeted respiratory therapies.
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FDA Puts Gilead’s HIV Combo Trials on Hold
Gilead
The FDA has paused five Gilead HIV combo trials over safety concerns, but the decision does not impact lenacapavir's upcoming PrEP approval. Gilead remains confident in its HIV pipeline and future plans.
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FDA Narrows Use of PD-1 Drugs in GI Cancers
FDA
The FDA has restricted Merck’s Keytruda and BMS’s Opdivo for use only in PD-L1-positive gastric, GEJ, and esophageal cancers, citing limited benefit in PD-L1-negative patients based on recent trial data.
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