Vanda, gastroparesis and tradipitant
FDA Rejects NK1R Antagonist for Gastroparesis
Support for the neurokinin-1 receptor (NK1R) antagonist included a negative phase III trial and a positive phase II study involving patients with diabetic or idiopathic gastropare
VNDA Stock Down as FDA Rejects NDA for Tradipitant in Gastroparesis
Vanda Pharmaceuticals Inc. VNDA announced that the FDA issued a complete response letter (CRL) to its new drug application (NDA) seeking approval for its pipeline candidate, tradipitant for the treatment of symptoms in gastroparesis.
Vanda slams FDA rejection of gastroparesis drug
The FDA has declined to approve Vanda Pharma's tradipitant for delayed gastric emptying (gastroparesis), prompting a furious response from the company.
FDA Strikes Off Vanda Pharmaceuticals' Tradipitant For Stomach Paralysis, Asks For Additional Studies
The FDA rejected Vanda Pharmaceuticals' new drug application for tradipitant to treat gastroparesis, citing the need for more studies despite delays in its review process. Vanda argues the drug meets efficacy standards and plans to continue pursuing approval.
FDA Rejects Vanda Pharma's Application for Gastroparesis Drug Tradipitant
Vanda said it will continue to pursue approval of tradipitant in gastroparesis, a condition that affects the stomach muscles and prevents proper stomach emptying, and that it plans to file a separate application later this year seeking a green light for the drug for the prevention of vomiting in motion sickness.
FDA rejects Vanda Pharmaceuticals' application to bring key drug to market
A D.C. drugmaker has been dealt a major setback in its long-running bid to bring its treatment for a chronic gastrointestinal disease to market.
FDA Declines to Approve Vanda's Marketing Application for Tradipitant in Gastroparesis
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today provided an update on its tradipitant development program.
Vanda slips as FDA rejects therapy for stomach condition
Vanda Pharmaceuticals (NASDAQ:VNDA) fell ~9% in the premarket on Thursday after the U.S. FDA declined to approve its marketing application for experimental therapy, tradipitant for a stomach-related medical condition called gastroparesis.
abp LIVE12h
What Is Gastroparesis? Unraveling This Digestive Disorder And Its Impact On Health | Health Live
Experts indicate that this rare disorder can lead to various uncomfortable symptoms, including nausea, vomiting, bloating, ...
Onlymyhealth7d
Why Does Gastroparesis Cause Challenges In Diagnosis, Treatment?
Gastroparesis is an often overlooked digestive disorder that significantly impacts the quality of life of those affected.
Evoke Pharma Reaffirms Its Commitment to Patients with Gastroparesis Amid Industry Developments
Gimoti remains the sole proprietary FDA approved treatment for symptoms of diabetic gastroparesisSOLANA BEACH, Calif., Sept.
FierceBiotech2d
Vanda receives FDA rejection, issues fiery response against ‘conclusory’ refusal
Vanda Pharmaceuticals has failed to persuade the FDA to approve its gastroparesis candidate on the strength of a phase 3 ...
Why Vanda Pharmaceuticals Stock Sank by Nearly 6% Today
The end of the trading week likely can't come fast enough for Vanda Pharmaceuticals ( VNDA -6.06%). The commercial-stage ...
Avenacy Announces Launch of Metoclopramide Injection, USP in the U.S. Market
Avenacy's Metoclopramide Injection, USP is available in 10 mg/2 mL (5 mg per mL) single-dose vials. In line with Avenacy’s ...