FDA News

The FDA identified high concentration of lidocaine across marketed, over-the-counter topical products from 6 different companies.

Michael Weber, MD, lead of the PRECISION trial, discusses the significance of the aprocitentan (Tryvio) approval and key points for providers who may have patients with uncontrolled hypertension.

The approval marks the first and only once-daily single-tablet combination therapy for patients with pulmonary arterial hypertension.

The FDA's approval of the label expansion for bempedoic acid to include cardiovascular risk reduction is based on data from the CLEAR Outcomes trial.

Idorsia Ltd. announced the FDA's approval of aprocitentan (Tryvio) for treatment-resistant hypertension on March 20, 2024.

The FDA has cleared Sequel's twiist, a novel automated insulin delivery system, expanding patient choice for individuals with type 1 diabetes.

Approvals by both the FDA and the Chinese NMPA have followed recent clinical trial data on spesolimab injection in GPP patients.

On March 15, 2024, the FDA approval of fluticasone propionate nasal spray marks the first approval in agency history for treatment of chronic rhinosinusitis without nasal polyps.

In a landmark decision, the FDA has granted accelerated approval to resmetirom (Rezdiffra) for noncirrhotic NASH with moderate to advanced fibrosis.

Saeed Mohammed, MD, MS, discusses maralixibat for pruritus in PFIC, describing how IBAT inhibitors have changed the way clinicians are able to treat cholestatic liver disease.

In an interview with HCPLive, Daniel Karlin, MD, discussed how their phase 2B trial demonstrated MM120’s durability through week 12 for the treatment of generalized anxiety disorder.

The submission could grant guselkumab its third indication, after being approved by the FDA for psoriasis and psoriatic arthritis.

Nearly a decade after becoming the first PCSK9 inhibitor to receive approval from the FDA, alirocumab (Praluent) has now received approval for pediatric patients with HeFH based on data from a phase 3 trial.

On March 08, 2024, the FDA approved semaglutide 2.4 mg (Wegovy) to reduce cardiovascular risk in adults with obesity or overweight and heart disease based on the SELECT trial.

FDA issued a Complete Response Letter to Vanda Pharmaceuticals stating tasimelteon for treating insomnia cannot be approved in its current form due to identified deficiencies.

The FDA has greenlit Dexcom's Stelo Glucose Biosensor System, marking a historic first as the first continuous glucose monitors to be available over-the-counter.

The decision was based on clinical studies demonstrating no clinically meaningful differences between the biosimilar and its reference product.

Clobetasol propionate ophthalmic suspension 0.05% for post-ocular surgery pain marks the first new steroid in the ophthalmic market in over 15 years.

The approval of the AGENT Drug-Coated Balloon is based on the AGENT IDE trial and was announced by Boston Scientific on March 01, 2024.

This announcement by UCB follows the results of four phase 3 studies on the use of bimekizumab for PsA, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.

Brassica Pharma Pvt. Ltd. is voluntarily recalling eye ointment products with expiration dates from February 2024 to September 2025.

Minerva Neurosciences announced the receipt of a Complete Response Letter for roluperidone in treatment of negative symptoms in patients with schizophrenia on February 27, 2024 despite clinical trial data indicating improved Negative Symptom Factor Scores and Personal and Social Performance scale scores.

The FDA’s decision is planned for June 2024, and follows the successful results of the BOREAS and NOTUS trials.

The approval is based upon phase 3 findings from the OUtMATCH study, representing the first treatment for adult and pediatric patients with accidental exposure to 1 or more food allergens.

FDA advisory committee votes 13-1 that the benefits outweigh the risk of use for Abbott's TriClip for tricuspid regurgitation, pending FDA decision expected in 2024.

The investigational antisense oligonucleotide’s designation is based on data from the phase 2b trials B-Clear and B-Sure.

HealthFLD, a fully automated AI software for liver attenuation analysis from CT scans, has received FDA 510(k) clearance for use in the general population.

The decision makes budesonide oral suspension (Eohilia) the first and only FDA-approved oral therapy for patients ≥ 11 years of age with eosinophilic esophagitis.

The FDA's acceptance of the NDA for acoramidis in ATTR-CM was announced on February 05, 2024 and assigns a November 2024 PDUFA for the agent.

This announcement is part of the overall evaluation period for the treatment, as the PDUFA target action date for pz-cel remains May 2024.