Vanda Pharmaceuticals Calls on FDA to Withdraw Proposal from FY 2027 Legislative Agenda That Would Extend Drug Review Timelines [Yahoo! Finance]
Vanda Pharmaceuticals Inc. (VNDA)
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Source: Yahoo! Finance
Vanda Logo (PRNewsfoto/Vanda Pharmaceuticals Inc.) The proposal would eliminate the simple statutory requirement that the FDA must review a new drug application (NDA) within 180 days of filing. In plain terms, this change would extend statutory review timelines rather than shorten them. It would replace the 180-day legal requirement with the longer Prescription Drug User Fee Act (PDUFA) and Generic Drug User Fee Amendments (GDUFA) performance goals. Under those goals, the FDA takes up to two months simply to decide whether to "file" the application. Only after that does the official review clock begin, resulting in typical total review times of 10 to 12 months from submission to decision. The proposal would also replace the formal evidentiary hearing process required by current law with a weaker, internal streamlined appeal. The FDA has avoided providing the statutorily mandated opportunity for a formal evidentiary hearing on drug non-approvals for over 40 years, until Vanda's
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VNDA
News
- Vanda Pharmaceuticals Calls on FDA to Withdraw Proposal from FY 2027 Legislative Agenda That Would Extend Drug Review Timelines [TheStreet.com]TheStreet.com
- Vanda Pharmaceuticals Calls on FDA to Withdraw Proposal from FY 2027 Legislative Agenda That Would Extend Drug Review TimelinesPR Newswire
- Vanda Pharmaceuticals Announces Initiation of The Thetis Study, a Clinical Trial of NEREUS™ for the Prevention of Vomiting Induced by GLP-1 Receptor Agonists [TheStreet.com]TheStreet.com
- Vanda Pharmaceuticals Announces Initiation of The Thetis Study, a Clinical Trial of NEREUS™ for the Prevention of Vomiting Induced by GLP-1 Receptor AgonistsPR Newswire
- Vanda Pharmaceuticals Calls for Stronger FDA Action to Accelerate Shift from Animal Testing to Human-Relevant Methods [Yahoo! Finance]Yahoo! Finance
VNDA
Earnings
- 2/11/26 - Miss
VNDA
Analyst Actions
- 2/23/26 - HC Wainwright
VNDA
Sec Filings
- 4/2/26 - Form 8-K
- 3/27/26 - Form SCHEDULE
- 3/10/26 - Form 8-K
- VNDA's page on the SEC website