FDA News

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.

VOQUENZA® provides quicker healing than Lansoprazole, according to an FDA-approved Phase 3 study

Secukinumab (Cosentyx) becomes the first IL-17A inhibitor, as well as the first drug since 2015, approved to treat adults with moderate to severe HS.

The FDA announced the approval of ustekinumab-auub (Wezlana) as a biosimilar and interchangeable to ustekinumab (Stelara) for a half dozen inflammatory conditions on October 31, 2023.

The FDA has expanded the approval of abatacept (Orencia) for the treatment of active psoriatic arthritis in patients aged 2 years and older.

On October 27, 2023, the FDA warned consumers to stop using ophthalmic products from 6 brands, including CVS Health and Rite Aid, after investigators found bacterial contamination at a manufacturing facility.

Genentech announced the FDA had approved faricimab-svoa (Vabysmo) for retinal vein occlusion on October 26, 2023, which marks the third ophthalmic indication for the bispecific antibody.

Eli Lilly and Company announced the FDA approval of mirikizumab (Omvoh) for moderately and severely active ulcerative colitis in adults on October 26, 2023.

The FDA has issued a Class I recall for some of Fresenius Medical Care's hemodialysis machines due to potential exposure to toxic compounds, affecting eight specific models from the 2008 Series.

The FDA has granted 510(k) Clearance to the Omnipod 5 app for iPhone, making Insulet Corporation the first to offer a tubeless AID system with smartphone control.