FDA News

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.

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.

The FDA has approved eplontersen (Wainua) for treating polyneuropathy in adult patients with hereditary transthyretin-mediated amyloidosis, making it the only medication approved for self-administration via auto-injector pen for this condition.

Based on the special protocol assessment submission, the company expects to begin the non-inferiority trial for the ophthalmic bevacizumab in the first quarter of 2024.

Budesonide is the first treatment to receive approval from the FDA for reducing the loss of kidney function in adults with primary IgAN.

The FDA’s approval of Chiesi Global Rare Diseases’ topical gel marks the first approval for the variant of EB known as JEB.

The decision by the FDA is a step closer to omalizumab’s potential approval, making it the potential first medicine to reduce reactions to many different food allergens after accidental exposure.

The approval of the once-daily, steroid free foam marks the first approval of a drug by the FDA for the skin condition with a new mechanism of action in around 2 decades.

This announcement may be considered further progress in the implementation of the FDA Overdose Prevention Framework designed to prevent overdoses and reduce mortality.

The New Drug Application submission is supported by data from a pair of phase 3 studies, a long-term open-label study, and prior phase 2 studies. Cymabay has also requested Priority Review of the NDA.

Announced by Glaukos on December 14, 2023, the prostaglandin analog approval is indicated for the reduction of intraocular pressure among patients with ocular hypertension or open-angle glaucoma.

The submissions to both agencies were based upon positive results from the BASIS trial that had been presented at the American Society of Hematology Annual Meeting.

The decision was based on both clinical and non-clinical data supporting the biosimilarity of bevacizumab-tnjn (Avzivi), previously named BAT1706.

The NDA submission was supported by positive data from the phase 3 PHALCON-NERD-301 study and has been assigned a standard 10-month review with a PDUFA target action date of July 19, 2024.

The approval was based on data from the APPLY-PNH trial and APPOINT-PNH study, which showed iptacopan was superior for hemoglobin improvement in the absence of red blood cell transfusions and in transfusion avoidance rate compared to patients who stayed on anti-C5 treatments.