MedPath

FDA Explains Why It Rejected Vanda's Stomach Drug in Late 2024

The FDA has provided an explanation for its rejection of Vanda's stomach drug in late 2024, as reported by Endpoints News.

The FDA has detailed its reasons for rejecting Vanda's stomach drug towards the end of 2024. This decision was highlighted in a report by Endpoints News, which focuses on the pharmaceutical and biotech industries. The article did not delve into specific details regarding the FDA's rationale for the rejection, nor did it provide information on the nature of Vanda's stomach drug or the clinical trials it underwent. The report primarily served as a notice of the FDA's decision without elaborating on the technical or scientific grounds for the rejection.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

FDA Approves Zepbound (tirzepatide) for Obstructive Sleep Apnea

The FDA has approved Zepbound (tirzepatide) for the treatment of moderate-to-severe obstructive sleep apnea (OSA) in adults, marking a significant advancement in OSA therapy.
The approval is based on positive results from the SURMOUNT-OSA clinical trials, which demonstrated significant reductions in apnea-hypopnea index (AHI) among participants.

Vanda Pharmaceuticals Challenges FDA Rejection of Tradipitant for Gastroparesis, Seeks Hearing

The FDA issued a Complete Response Letter for Vanda Pharmaceuticals' tradipitant, a neurokinin-1 receptor antagonist, for treating gastroparesis, citing insufficient evidence of efficacy.
Vanda disputes the FDA's assessment, asserting that tradipitant has demonstrated substantial evidence of efficacy and a favorable benefit-risk profile in clinical studies.

Neurocrine Biosciences' Crinecerfont Receives FDA Approval for Congenital Adrenal Hyperplasia

The FDA has approved Crinecerfont, developed by Neurocrine Biosciences, as the first drug in decades for congenital adrenal hyperplasia (CAH).
Crinecerfont is designed to reduce elevated androgen levels in individuals with CAH, addressing a critical unmet need in current treatment.

FDA Revokes Emergency Use Authorization for Bebtelovimab Due to Expired Lots and Variant Resistance

The FDA revoked the Emergency Use Authorization (EUA) for bebtelovimab on December 5, 2024, following a request from Lilly due to the expiration of all manufactured lots.
Bebtelovimab was no longer authorized for use in regions where SARS-CoV-2 variants demonstrated resistance, based on available susceptibility data and variant frequency.

FDA Approvals in 2024: NASH Treatment, DMD Therapy, Novel Schizophrenia Drug, and Breast Cancer Advancement

The FDA approved Rezdiffra (resmetirom) as the first specific treatment for nonalcoholic steatohepatitis (NASH), addressing a critical unmet need for patients with liver damage.
Duvyzat (givinostat) gained approval as the first nonsteroidal treatment for all genetic variants of Duchenne muscular dystrophy (DMD), offering a new option for patients aged 6 and older.

enVVeno Medical Seeks FDA Approval for VenoValve in Severe Chronic Venous Insufficiency

enVVeno Medical has submitted its Premarket Approval (PMA) application to the FDA for VenoValve, a surgical replacement venous valve.
The VenoValve is intended for treating severe deep venous Chronic Venous Insufficiency (CVI), a condition affecting approximately 2.5 million people in the U.S. annually.

FDA Rejects Vanda Pharmaceuticals' Fanapt for Gastroparesis

The FDA has declined to approve Vanda Pharmaceuticals' supplemental New Drug Application (sNDA) for Fanapt (iloperidone) in treating gastroparesis, a stomach condition characterized by delayed gastric emptying.
This rejection marks a setback for Vanda, which sought to expand Fanapt's indication beyond its current approval for schizophrenia, addressing an unmet need in gastroparesis management.

FDA Rejects Vanda's Tradipitant for Gastroparesis, Citing Insufficient Evidence

The FDA issued a Complete Response Letter for Vanda Pharmaceuticals' tradipitant, a neurokinin-1 receptor antagonist, for treating gastroparesis symptoms.
The FDA's decision was based on the need for additional studies, which Vanda argues are inconsistent with expert advice and current understanding of gastroparesis.

FDA Extends Review of Revumenib for KMT2A-Rearranged Acute Leukemia

The FDA extended the PDUFA action date for revumenib by three months, now set for December 26, 2024, to allow for a comprehensive review of supplemental data.
Revumenib targets KMT2A-rearranged acute leukemia, addressing a significant unmet need in both adult and pediatric patients with relapsed or refractory disease.

FDA Approves Femlyv, First Orally Disintegrating Birth Control Pill

The FDA has approved Femlyv (norethindrone acetate and ethinyl estradiol) as the first orally disintegrating tablet for pregnancy prevention.
Femlyv offers an alternative for individuals who experience difficulty swallowing traditional pills, expanding access to contraception.

Reference News

[1]
FDA explains why it rejected Vanda's stomach drug in late 2024 - Endpoints News
endpts.com · Jan 16, 2025

Endpoints subscribers can request a magic link via email for quick, password-free login, valid once and expires in 24 ho...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy