FDA News

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.

BLA submission was based on data from phase 3 clinical trials in which DMB-3115 showed no clinically meaningful differences compared with the reference product for the treatment of plaque psoriasis.

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.

Announced on December 04, 2023, the approved label changes allow for administration regardless of timing of proton pump administration and for administration 15 minutes before breakfast.

The FDA will decide on the approval of xanomeline-trospium, a dual M1/M4 muscarinic acetylcholine receptor agonist in the central nervous system, for the treatment of schizophrenia patients by September 2024.

The FDA issued a warning about the DreamStation 2 CPAP Machine, which is used to treat obstructive sleep apnea, due to reports of the device overheating and leading to fires, smoke, and burns.

The approval is the first for a systemic therapy to treat desmoid tumors, offering patients an alternative to surgery.

The FDA has approved the second renal denervation device in the agency's history with the approval of Medtronic's Symplicity Spyral system.

This news from the FDA followed a resubmission after the FDA’s complete response letter for the P2X3 receptor antagonist’s use in refractory chronic cough and unexplained cough.

Per the FDA, Kilitch Healthcare India Limited voluntarily recalls 27 eye drop items, including those distributed by CVS, Rite Aid, and Target, due to potential safety issues.

On November 15, 2023, the FDA approved Defencath. The new drug can reduce catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter.

Sent on November 13, 2023, the FDA letter warns Amazon on the introduction of unapproved new eye drop products into interstate commerce on their website.

On November 7, 2023, Recor Medical announced the FDA approval of their Paradise Ultrasound Renal Denervation system for the treatment of hypertension.

In this episode, hosts discuss the FDA's approval of tirzeptiade (Zepbound) as an adjunct to lifestyle modification for the chronic weight management in people with overweight or obesity.

Announced on November 8, 2023, the approval of tirzepatide(Zepbound) was awarded to Eli Lilly and Company and represents the first chronic weight management approval for a dual GLP-1/GIP receptor agonist.

Consumers should avoid Dr. Ergin’s SugarMD Advanced Glucose Support due to an increased risk of adverse events including hypoglycemia.