FDA News

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

In this interview, Dr. Chovatiya responds to questions about the new FDA approval of secukinumab for patients with hidradenitis suppurativa.

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.

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.

Announced by Milestone Pharmaceuticals on October 24, 2023, the New Drug Application includes positive results on etripamil from the pivotal phase 3 RAPID trial.

Samsung Bioepis gains FDA interchangeability designation for its ranibizumab (Lucentis) biosimilar, ranibizumab-nuna (Byooviz), in the treatment of wAMD, macular edema following RVO, and mCMV

The first-of-its-kind Aurora EV-ICD system offers a single-device, single procedure with a lead placed outside of the heart and veins.

Dr. Eichenfield used this interview segment to respond to the FDA’s recent decision not to approve dupilumab for chronic spontaneous urticaria.

Designed to treat the acne's inflammation, bacteria and follicular hyperkeratinization, IDP-126 has shown significant efficacy compared to standard-care options already on the market.

The latest indication for the dual inflammatory pathway-targeting biologic expands dupilumab's clinical availability to third chronic skin disease.

The expanded Indication now includes children of all ages with achondroplasia, the most common form of skeletal dysplasia leading to disproportionate short stature.

Results from the phase 3 NEAR-1 and NEAR-2 clinical trials show consistent efficacy and tolerability of the preservative-free, low-dose eye drop in patients with presbyopia.