FDA, Vanda
US FDA declines to approve Vanda's stomach condition drug
Vanda Pharmaceuticals said on Thursday the U.S. Food and Drug Administration declined to approve its drug to treat a type of stomach condition that disrupts digestion and called for additional studies.
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.
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.
U.S. FDA declines to approve Vanda's stomach paralysis drug
The U.S. Food and Drug Administration has declined to approve Vanda Pharmaceuticals' drug to treat stomach paralysis symptoms, the company said on Thursday. Shares of the company fell about 14% to $4.
Vanda Pharmaceuticals decries FDA’s rejection of stomach paralysis drug as unjust
Vanda pharmeucitals received a rejection for its drug tradipitant, causing the company management to criticize the FDA.
Vanda slips as FDA rejects therapy for stomach condition
Vanda Pharmaceuticals (VNDA) stock saw a 9% premarket drop after FDA rejection of its therapy for gastroparesis, citing need for additional studies. Read more here.
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.
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.
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 ...
FierceBiotech4d
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 ...
Eco-business3d
Vanda RE’s energy export project achieves major development milestones, accelerating path to commercial viability
Vanda RE Pte Ltd, a joint venture company majority-owned by Gurīn Energy, announced today that it has been awarded a ...
Approvals News | Today's Latest Stories | Reuters
Reuters.com is your online source for the latest news stories and current events, ensuring our readers up to date with any ...
FDA拒绝Vanda Pharmaceuticals的胃轻瘫药物申请
Vanda Pharmaceuticals Inc. (NASDAQ: VNDA)周三宣布,美国食品和药物管理局(FDA)未批准其新药申请(NDA),该申请旨在使用tradipitant治疗胃轻瘫症状。FDA通过完整回复信(CRL)向Vanda传达了这一决定。 胃轻瘫是一种慢性疾病,会阻碍胃部正常排空,导致恶心和呕吐等严重症状。尽管有两项安慰剂对照研究支持tradipitant的有效性,但FDA要 ...
Dagens News (US) on MSN17h
Three Young Lionesses Escape War in Ukraine for a New Life in Britain
In a heartwarming tale of rescue and hope, three young lionesses have embarked on a long journey from the war-torn regions of ...
BioPharma Dive3d
Novo sinks on obesity drug results; Sanofi reveals anticipated MS data
A pill Novo acquired produced modest weight loss but raised safety questions. Elsewhere, Sanofi detailed the silver lining it found in a recent study and a heart drug developer’s shares surged.