FDA News

This episode highlights the groundbreaking approval of semaglutide for metabolic dysfunction-associated steatohepatitis, as well as GoodRx’s new Ozempic pricing.

The FDA has approved Ionis Pharmaceuticals' donidalorsen to prevent HAE attacks in adults and children over 12 years.

With positive topline phase 2 results, parent company Crinetics Pharmaceuticals, Inc., has announced plans to begin phase 3 testing in the second half of 2025.

The accelerated approval is based on findings from Part 1 of the ESSENCE trial and indicates the agent for noncirrhotic MASH with moderate to advanced fibrosis.

The therapy's, marketed as Papzimeos, approval is supported by data from a pivotal Phase 1/2 clinical trial.

Over 11,000 bottles have been voluntarily recalled in response to a consumer complaint of a foreign substance inside a tablet, later identified as aluminum.

The therapy was approved based off of positive data from the pivotal ASPEN trial.

FDA grants Fast Track to NRX-100, the first preservative-free IV ketamine, for treating suicidal ideation in depression.

After overcoming 2 FDA rejections, PharmaTher secures approval for ketamine (KETARX) in surgical pain.

Teva’s AJOVY (fremanezumab) becomes the first CGRP antagonist approved by the FDA for pediatric patients with episodic migraine.

Recent FDA approvals of pegcetacoplan and iptacopan revolutionize C3 glomerulopathy treatment, offering hope and targeted options for patients.

C3G treatment options expand with FDA approvals of pegcetacoplan and iptacopan, offering new hope for patient care.

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

The therapy was originally approved under the name Alhemo for people with hemophilia ages 12 and up without inhibitors.

FDA approves aceclidine ophthalmic solution 1.44%, revolutionizing presbyopia treatment for millions with a once-daily eye drop.

The new requirements follow a May Advisory Committee meeting that went over the latest long-term data on opioid risks.

Inclisiran can now be used alone, without addition of statin therapy, as adjunct to diet and exercise for LDL-C reduction in hypercholesterolemia.

FDA approves pegcetacoplan (Empaveli) for treating C3 glomerulopathy and primary IC-MPGN, offering hope for patients aged 12 and older.

The approval was based on positive results from the phase 3 foresiGHt trial and expands upon the indication for pediatric growth hormone deficiency.

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.