This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
Vamorolone , sold under the brand name Agamree , is a synthetic corticosteroid , which is used for the treatment of Duchenne muscular dystrophy. [4] 10] Vamorolone was approved for medical use in the United States in October 2023, [11] [10] and in the European Union in December 2023. [2] Treatment of crude 9.3
Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDAAPPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDAAPPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 9] It is used as landiolol hydrochloride.
Eplontersen , sold under the brand name Wainua , is a medication used for the treatment of transthyretin-mediated amyloidosis. [1] 2] [3] [4] [5] It was approved for medical use in the United States in December 2023. [6] 2] [3] [4] [5] It was approved for medical use in the United States in December 2023. [6] 7 March 2023.
Steve Mason, Co-Chief Operating Officer, Altasciences, added: “The creation of AnQlar as a treatment, if successful, could be a huge leap forward in preventing the spread of influenza and similar viruses. Virpax is initially seeking FDAapproval for two prescription drug candidates that employ two different patented drug delivery platforms.
Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDAapproved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders.
Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDAapproved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders.
Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDAapproval so long as it adhered to pre-set terms under the monograph. The FDA will follow these procedures for both agency-initiated operations (e.g.,
Each committee is comprised of a number of experts, diverse for their expertise, geography and specialty – with some focused on statistics while others may be focused on areas of concentration within the category, such as the treatment of pediatric patients.
Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in November and December FDA comment periods are typically open for 30-60 days, unless they are extended.
FDA’s guidance on developing products to prevent or treat Covid-19 Of the five guidance documents that received an extension, one addresses the development of drugs and biological products for Covid-19. One topic that is still not covered by this, or any, guidance – the treatment or prevention of Long Covid-19.
The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List.
No statistically significant difference was demonstrated for secondary endpoints including overall survival (OS), time to initiation of cytotoxic chemotherapy, chronic opioid use, and pain progression between treatment arms. Grade 3/4 treatment emergent adverse events (TEAEs) were reported in 63.3 percent in the control arm.
12/29/2023 FDORA, Section 3202 Orphan Drug Program : FDA will convene a public meeting (or several) to solicit input from stakeholders regarding rare disease patient burdens, treatment options, side effects of treatments, etc.
1] [2] [3] Iomeprol was approved for medical use in the United States in November 2024. [1] Article ] Rosati G: Clinicalpharmacology of iomeprol. Meanwhile, the used starting material (compound II) is a common intermediate of other contrast agents iohexol and ioversol, so that corresponding supporting construction is reduced.
Medical uses Acoramidis is indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization. [1] 6] [7] [19] The approval was granted to BridgeBio Pharma. [10] g, 83.2%) as an off-white solid.
We organize all of the trending information in your field so you don't have to. Join 15,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content