Remove Containment Remove FDA Approval Remove Hormones Remove Marketing
article thumbnail

The regulatory round-up: Eight key FDA decisions

Drug Discovery World

Orserdu (elacestrant), Stemline Therapeutics The first and only treatment specifically indicated for patients with ESR1 mutations in ER+, HER2- advanced or metastatic breast cancer was approved in the US in February. This made Jesduvroq is the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to be approved in the US.

article thumbnail

Top 15 Diabetes Drugs in 2023 by 2022 Sales Statistics

XTalks

Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries. Ozempic (Semaglutide) Ozempic sales in 2022: $8.713 billion Company/Developer: Novo Nordisk Date of first FDA approval: December 5, 2017 Indications Ozempic is FDA-approved for: Type 2 diabetes Price of Ozempic: $1,029 for 1.5

Sales 52
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

J&J’s Akeega Approved as First Combo Treatment for BRCA-Positive Prostate Cancer

XTalks

The Janssen Pharmaceutical Companies of Johnson & Johnson announced yesterday that the US Food and Drug Administration (FDA) has granted marketing authorization for its combination treatment Akeega for metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 mutations.

article thumbnail

Harmony Biosciences Receives FDA Approval For Expanded Use Of WAKIX® (pitolisant) For The Treatment Of Cataplexy In Adult Patients With Narcolepsy

The Pharma Data

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

article thumbnail

Zepbound, Obesity Version of Eli Lilly’s Mounjaro, Finally Gets FDA Nod

XTalks

Eli Lilly is now fully armed on the GLP-1 front as it’s finally received US Food and Drug Administration (FDA) approval for Zepbound (tirzepatide), its obesity version of Mounjaro. The FDA approved Zepbound for chronic weight management in adults with obesity.

article thumbnail

Creating Future of MedTech Industry with Artificial Intelligence

Delveinsight

Banyan Biomarkers is one company to be able to market a blood-based diagnostic test in the US market, as it utilizes tech to aid the detection of traumatic brain injuries and concussions. In February 2018, the San Diego-based company was granted a de novo request from FDA for the Banyan Brain Trauma Indicator.

Protein 56
article thumbnail

GLP-1 Agonists for Diabetes: Mounjaro Versus Ozempic

XTalks

Glucagon-like peptide-1 (GLP-1) receptor agonists are a newer class of diabetes drugs that have the potential to double as weight loss drugs, widening their lucrative market potentials. Novo’s obesity version of semaglutide (at a higher dose) is marketed as Wegovy and was approved in 2021. billion in 2021 to $61.6

Insulin 98