Vanda Announces FDA Grants Landmark Hearing for HETLIOZ® in Jet Lag Disorder, the First Drug Approval Hearing in Over 40 Years [Yahoo! Finance]
Vanda Pharmaceuticals Inc. (VNDA)
Last vanda pharmaceuticals inc. earnings: 2/25 04:01 pm
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Source: Yahoo! Finance
Food and Drug Administration (FDA) has granted the company's request for a formal evidentiary public hearing to review the Center for Drug Evaluation and Research's (CDER) proposal to refuse approval of Vanda's supplemental new drug application (sNDA) for HETLIOZ ® (tasimelteon) in the treatment of jet lag disorder. Vanda Logo (PRNewsfoto/Vanda Pharmaceuticals Inc.) The FDA confirmed the decision to grant a hearing in a letter from the Office of the Commissioner dated March 2, 2026. The hearing will proceed under 21 CFR Part 12, after which the presiding officer will issue an initial decision pursuant to 21 CFR § 12.120. Granting a formal evidentiary public hearing in response to a proposed refusal to approve a drug application is a rare and highly significant regulatory step. Publicly available records and historical accounts indicate that the FDA has not granted such a hearing under 21 CFR Part 12 in the context of drug approvals for decades—potentially over 40 years—underscor
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VNDA
News
- Vanda Pharmaceuticals (VNDA) is now covered by Truist Financial Corporation. They set a "buy" rating and a $18.00 price target on the stock.MarketBeat
- Vanda Announces FDA Grants Landmark Hearing for HETLIOZ® in Jet Lag Disorder, the First Drug Approval Hearing in Over 40 YearsPR Newswire
- Vanda Pharmaceuticals Announces Participation in the 2026 Citizens Life Sciences ConferencePR Newswire
- Vanda Pharmaceuticals Announces FDA Acceptance of Biologics License Application Filing for Imsidolimab for the Treatment of Generalized Pustular Psoriasis [Yahoo! Finance]Yahoo! Finance
- Vanda Pharmaceuticals Announces FDA Acceptance of Biologics License Application Filing for Imsidolimab for the Treatment of Generalized Pustular PsoriasisPR Newswire
VNDA
Earnings
- 2/11/26 - Miss
VNDA
Sec Filings
- 3/4/26 - Form 4
- 3/4/26 - Form 4
- 3/4/26 - Form 4
- VNDA's page on the SEC website