FDA News

FDA approval of topical delgocitinib marks a long-awaited treatment milestone for adults with chronic hand eczema.

Although shown to have no connection to autism in multiple studies, the mercury-based agent will no longer be included in multidose influenza shots.

FDA approves delgocitinib cream, offering a new treatment option for adults with moderate-to-severe chronic hand eczema.

The announcement of this NDA submission to the FDA highlights icotrokinra, a first-in-class investigational targeted oral peptide for plaque psoriasis.

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

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.

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.

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.

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.

The results of the ZENITH trial have encouraged the expansion of sotatercept’s label to patients with prior background therapy.

A relatively quiet quarter for hematology, punctuated by both successes and failures in clinical trials and a handful of Orphan Drug and Fast Track designations.

This FDA news recap highlights some of the most notable approvals and actions by the organization in dermatology during Q2 2025.

Discover groundbreaking FDA approvals in 2025 that redefine treatment standards, enhance patient care, and address critical public health needs.

The CRL cited deficiencies previously identified at a third-party manufacturing vendor unrelated to OLC, and the Company plans to request a Type A meeting.

A form of the cytisine regimen, widely used in Eastern Europe for decades, is finally being put in front of US regulators after recently also becoming available in the UK.

Hereditary hemorrhagic telangiectasia has no approved treatments; this designation, in addition to the European Medicines Agency granting a positive opinion, positions DIAG723 to be the first.

This update by FDA officials extends the review period for ruxolitinib cream as a treatment for atopic dermatitis in children aged 2-11 years.

Nitisinone is the first and only FDA-approved treatment for AKU, a rare genetic disease without a known cure.

Dupilumab (Dupixent) approved as the first targeted therapy for bullous pemphigoid, marking 8th indication for diseases with type 2 inflammation.

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.

The FDA approves Lenacapavir, a groundbreaking twice-yearly HIV prevention injection, revolutionizing PrEP options for adults and adolescents.