A PDUFA target date of January 31, 2024 has been set for the application.
The iLet Bionic Pancreas uses an adaptive closed-loop algorithm requiring only a user’s body weight for start-up and no additional insulin dosing parameters.
Miebo is supplied in multiple-dose 5mL bottles and is expected to be available in the second half of 2023.
Findings showed faricimab was associated with rapid drying of retinal fluid.
MydCombi is a combination of tropicamide, an anticholinergic, and phenylephrine hydrochloride, an alpha-1 adrenergic receptor agonist.
Arexvy is expected to be available for the 2023-2024 RSV season.
Akorn ceased and shutdown all operations following a Chapter 7 bankruptcy filed on February 23, 2023.
The FDA has approved Qalsody (tofersen) for the treatment of adults with ALS who have a mutation in the SOD1 gene.
Omnipod GO is a tubeless and waterproof insulin delivery system.
Resilia Pharmaceuticals has announced the relaunch of Solace Cream for the treatment of signs and symptoms of eczema.
Only the 60mg dose of Qulipta is indicated for the preventive treatment of chronic migraine.
Tepezza is a human insulin-like growth factor-1 receptor inhibitor.
The FreeStyle Libre 3 reader is a standalone, small handheld device that displays real-time glucose readings.
SAB-176 is a fully-human broadly neutralizing immunoglobulin antibody therapeutic.
KPI-012 is a topically dosed ophthalmic therapy designed using the Company’s human mesenchymal stem cell secretome platform.
InflaRx is working to increase supply of the product in the US as quickly as possible.
Vuity contracts the iris sphincter muscle, constricting the pupil to improve near and intermediate visual acuity.
The Lucira COVID-19 & Flu Home Test is available at a price of $34.99.
Novo Nordisk plans to file for regulatory approval of the 25mg and 50mg dosage strengths in 2023.
Zavzpret (zavegepant) nasal spray is a calcitonin gene-related peptide (CGRP) receptor antagonist.
The product is used as an anti-inflammatory intended to relieve ocular irritation and/or swelling.
The sNDA is supported by data from the phase 3 DINAMO trial, which include patients 10 to less than 18 years of age with type 2 diabetes who are currently receiving metformin, insulin, or both.
The FDA panel reviewed data from 5 clinical studies, including the phase 3 AReSVi 006 trial.
Elyxyb is a ready-to-use oral solution formulation of celecoxib, a nonsteroidal anti-inflammatory drug.
The designation is supported by data from the ongoing phase 2 KEYNOTE-942 study, which included 157 patients with stage III/IV melanoma following complete resection.
The approval was based on data from the phase 3 DERBY and OAKS studies.
The BLA is supported by data from the pivotal PULSAR and PHOTON trials.
The studies evaluated routine clinical practice data from more than 800 hospitals in the US.
The letters cite violations related to drug misbranding failing to bear adequate directions for their intended use(s).
The approval was based on data from a clinical program that included 23 clinical trials enrolling more than 5000 adults with type 2 diabetes mellitus.
