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July 17, 2025
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Announced by Aldeyra Therapeutics, Inc. on July 17, the FDA also assigned a PDUFA target action date of December 16, 2025.
July 14, 2025
The previously approved technology has already accomplished over 10,000 procedures for patients with various heart diseases, primarily including atrial fibrillation.
Finerenone gains FDA approval for heart failure treatment, offering new hope for patients with reduced ejection fraction and improving care options.
July 11, 2025
The FDA also announced an updated PDUFA date of December 13, 2025 for the self-administered nasal spray.
Capricor Therapeutics intends to resubmit a BLA for the potential first-in-class treatment with topline data from the ongoing HOPE-3 trial in Q3 2025.
July 10, 2025
Transcend Therapeutics' TSND-201 gains FDA Breakthrough Therapy designation, offering new hope for rapid PTSD treatment with promising clinical trial results.
The initial batch of published CRLs are associated with since-approved applications in an effort to increase transparency and provide insight into the decision-making process.
July 07, 2025
KalVista's therapy is now approved under the name Ekterly, the first oral therapy for hereditary angioedema, empowering patients with timely, on-demand treatment options.
July 02, 2025
A review of the 16 novel drugs approved by the US Food and Drug Administration during the first half of 2025, with links to coverage from MJH Life Sciences publications.
This FDA News Month in Review provides a round-up of regulatory decisions from June 2025.