FDA News

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.

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.

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.

Stay updated with the latest healthcare breakthroughs, including FDA approvals and new phase 3 clinical trial data, in this week's essential news roundup.

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.

If approved, mavorixafor will be the second FDA-approved treatment and the first oral medication for CN.

FDA approves the new therapy under the name Enflonsia, offering effective RSV prevention for infants during their first RSV season.

Richard Lafeyette, MD, discusses his reaction to the phase 3 ORIGIN topline results and what it means for IgAN.

Sciurba shared his excitement for the recent approval of mepolizumab for people with COPD and an eosinophilic phenotype.

Discover key advancements and setbacks in cardiovascular medicine from May 2025, shaping the future of cardiometabolic care and treatment options.