Articles

Poll

Podcasts

Slideshows

Videos

Announced by Aldeyra Therapeutics, Inc. on July 17, the FDA also assigned a PDUFA target action date of December 16, 2025.

FDA Accepts Reproxalap Application for Dry Eye Disease

The previously approved technology has already accomplished over 10,000 procedures for patients with various heart diseases, primarily including atrial fibrillation.

FDA Approves Updated VARIPULSE Platform Irrigation Flow Rate for Heart Disease

Finerenone gains FDA approval for heart failure treatment, offering new hope for patients with reduced ejection fraction and improving care options.

FDA Approves Finerenone (Kerendia) for Heart Failure with Ejection Fraction of 40% or More

The FDA also announced an updated PDUFA date of December 13, 2025 for the self-administered nasal spray.

FDA Accepts Response to CRL for Etripamil (Cardamyst) for Treating PSVT

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.

FDA Issues CRL to Deramiocel for Treating Cardiomyopathy Secondary to DMD

Transcend Therapeutics' TSND-201 gains FDA Breakthrough Therapy designation, offering new hope for rapid PTSD treatment with promising clinical trial results.

FDA Grants TSND-201 Breakthrough Therapy Designation for PTSD

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.

FDA Publishes CRLs for Past Drug, Biological Product Applications

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.

Sebetralstat FDA-Approved as First Oral, On-Demand for Hereditary Angioedema

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.

FDA News Recap: Novel Drug Approvals in First Half of 2025

This FDA News Month in Review provides a round-up of regulatory decisions from June 2025.
