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June 19, 2025
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With the FDA acceptance of the NDA, the agency has assigned a PDUFA target action date of January 31, 2026, and may require an Advisory Committee meeting for approval.
June 18, 2025
The FDA approves Lenacapavir, a groundbreaking twice-yearly HIV prevention injection, revolutionizing PrEP options for adults and adolescents.
June 17, 2025
The monoclonal antibody garadacimab-gxii offers once-monthly, citrate-free dosing to prevent hereditary angioedema attacks in patients aged ≥ 12 years.
The company believes results from a recent phase 3 chamber trial fulfill the FDA’s requests in the Complete Response Letter received in April of 2025.
June 16, 2025
GMRx2 is now the first and only FDA-approved triple combination medication for use as an initial therapy in patients needing multiple drugs to lower blood pressure.
June 14, 2025
Stay updated with the latest healthcare breakthroughs, including FDA approvals and new phase 3 clinical trial data, in this week's essential news roundup.
June 12, 2025
Parent company Amneal Pharmaceuticals, Inc. has announced intentions to launch the topical anti-inflammatory agent in the third quarter of 2025.
The label expansion makes glecaprevir/pibrentasvir the first and only oral 8-week pangenotypic treatment option approved for people with acute or chronic HCV.
June 10, 2025
If approved, mavorixafor will be the second FDA-approved treatment and the first oral medication for CN.
June 09, 2025
FDA approves the new therapy under the name Enflonsia, offering effective RSV prevention for infants during their first RSV season.
