FDA News

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.

The FDA approval of Edwards Lifesciences EVOQUE tricuspid valve replacement system for treatment of symptomatic severe tricuspid regurgitation is the first of its kind for a transcatheter therapy.

This new warning for consumers cautions against use of Rebright, South Moon, or FivFivGo eye drops as a result of potential eye infection risks.

Following the January 25, 2024 approval of dupilumab for eosinophilic esophagitis in patients 1-11 years of age, a trio of pediatric gastroenterologists shares their thoughts on the new indication, their anticipated priority of use, and potential hurdles to optimal treatment uptake.

We sat down with Evan Dellon, MD, MPH, to discuss the use of dupilumab in pediatric EoE patients, with the agent gaining FDA approval as the first and only indication for this patient population on January 25, 2024.

On January 25, 2024, the day following the proposed PDUFA goal date, Liquidia Corporation announced the FDA was still reviewing the NDA for pulmonary hypertension with interstitial lung disease for treprostinil inhalation powder (Yutrepia).

On January 23, 2024, Heron Therapeutics announced the FDA had approved its sNDA for bupivacaine and meloxicam extended-release solution to expand the indication to include soft tissue and orthopedic surgical procedures, including procedures in which direct exposure to articular cartilage is avoided.

On January 19, 2024, the FDA announced the addition of a Boxed Warning to the labeling of denosumab (Prolia), citing evidence of an increased risk of severe hypocalcemia in patients with chronic kidney disease.

The FDA has extended the shelf-life of 4 mg naloxone hydrochloride nasal spray (Narcan) for nonprescription over-the-counter use from 3 years to 4 years.

The FDA grants the company agreement under a Special Protocol Assessment to evaluate TRS01 ophthalmic solution for the treatment of non-infectious uveitis, including uveitic glaucoma.

The FDA decision on berdazimer gel, 10.3%, represents the second approved treatment for the viral-borne skin disease.

For the first time, the FDA has approved a plan allowing Florida to import certain, cheaper prescription drugs from Canada.