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28.11.2025
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Vanda Pharmaceuticals Provides Regulatory Update on Tradipitant for Motion Sickness
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FDA requests, and Vanda agrees to, a brief extension (to December 5, 2025) for the expedited re-review of the partial clinical hold on long-term studiesSeparately, FDA recently issued labeling comments, and labeling discussions have formally begun for the New Drug Application of tradipitant for the prevention of vomiting induced by motion (PDUFA t...
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18.11.2025
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Vanda Pharmaceuticals Reports Positive Results for Tradipitant in Preventing GLP-1 Induced Nausea and Vomiting
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Vanda's Tradipitant Study Success Positions it as Key Adjunct in $50B+ Global GLP-1 Agonist Market
WASHINGTON, Nov. 17, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA), a leading biopharmaceutical company focused on the development and com...
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05.11.2025
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Vanda Pharmaceuticals Announces Participation in the Stifel 2025 Healthcare Conference
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WASHINGTON, Nov. 5, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the Stifel 2025 Healthcare Conference in New York City on Wednesday, November 12, 2025. A corporate presentation is scheduled for 4:40 p.m. Eastern Time....
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20.10.2025
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29.10.2025
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Vanda Pharmaceuticals Reports Third Quarter 2025 Financial Results
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Fanapt® Q3 2025 net product sales increased by 31% to $31.2 million compared to Q3 2024
BysantiTM (milsaperidone) NDA for bipolar I disorder and schizophrenia under review by the FDA; PDUFA target action date of February 21, 2026...
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20.10.2025
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22.10.2025
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Vanda Pharmaceuticals to Announce Third Quarter 2025 Financial Results on October 29, 2025
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WASHINGTON, Oct. 22, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the third quarter 2025 on Wednesday, October 29, 2025, after the market closes....
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08.10.2025
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Monumental Sports & Entertainment Taps D.C.'s Own Vanda Pharmaceuticals as Founding Partner to Help Drive the Creation of Brand-New Downtown Arena
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Multiyear agreement includes exclusive Monumental Sports Network studio entitlement, activations across Capitals, Wizards, and Mystics, and deep integration via community and media platforms
For photos of the new Vanda Pharmaceuticals Studio...
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01.10.2025
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Vanda Pharmaceuticals Announces Collaborative Framework for Resolution of Disputes with the U.S. Food and Drug Administration
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WASHINGTON, Oct. 1, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has agreed on a collaborative framework with the U.S. Food and Drug Administration (FDA) for the resolution of certain disputes regarding HETLIOZ® (tasimelteon) and tradipitant....
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25.09.2025
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Vanda Pharmaceuticals announces the publication in PLOS One of an article titled "Melatonin agonist tasimelteon (HETLIOZ®) improves sleep in patients with primary insomnia: A multicenter, randomized, double-blind, placebo-controlled trial"
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WASHINGTON, Sept. 25, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the publication of an article titled "Melatonin agonist tasimelteon (HETLIOZ®) improves sleep in patients with primary insomnia: A multicenter, randomized, double-blind, placebo-controlled trial" in PLOS One, a leading open-access journal....
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28.08.2025
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Vanda Pharmaceuticals Announces Participation at September 2025 Investor Conferences
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WASHINGTON, Aug. 28, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the following upcoming investor conferences in September 2025:
The Cantor Global Healt...
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28.08.2025
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Vanda Pharmaceuticals Announces FDA Granted Orphan Drug Designation for VGT-1849B, a Novel and Selective Candidate for the Treatment of Polycythemia Vera
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WASHINGTON, Aug. 28, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for VGT-1849B, a selective peptide nucleic acid-based JAK2 inhibitor for the treatment of polycythemia vera (PV)....
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18.08.2025
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In a Major Win for Vanda, a Federal Appeals Court Overturns FDA's Order Denying Approval of Hetlioz for the Treatment of Jet Lag Disorder
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WASHINGTON, Aug. 18, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it secured a landmark victory over the U.S. Food and Drug Administration (FDA) in its longstanding dispute with the agency regarding the approvability of HETLIOZ® (tasimelteon) to treat jet lag disorder (Vanda Pharmaceuticals Inc. v. F...
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23.07.2025
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Vanda Pharmaceuticals to Announce Second Quarter 2025 Financial Results on July 31, 2025
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WASHINGTON, July 23, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the second quarter 2025 on Thursday, July 31, 2025, before the market opens. ...
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20.10.2025
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10.06.2025
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Vanda Pharmaceuticals Announces First Patient Dosed in a Trial Evaluating VCA-894A in Charcot-Marie-Tooth disease Type 2S
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WASHINGTON, June 10, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the first dose in the first-in-human clinical trial to evaluate the safety and tolerability of VCA-894A, an antisense oligonucleotide (ASO) therapeutic, for a patient with a rare variant in the IGHMBP2 gene causing Charcot-Marie-Tooth disea...
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27.05.2025
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Vanda Pharmaceuticals Announces Presentation at 2025 ASCP Annual Meeting
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WASHINGTON, May 27, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced participation at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, to be held in Scottsdale, Arizona, from May 27 through May 30, 2025....
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16.05.2025
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Vanda Pharmaceuticals Announces Participation in the Mizuho Neuro & Ophthalmology Summit 2025
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WASHINGTON, May 16, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in investor meetings at the Mizuho Neuro & Ophthalmology Summit 2025 in New York City on Wednesday, May 21, 2025....
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07.05.2025
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Vanda Pharmaceuticals Reports First Quarter 2025 Financial Results
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Fanapt® Q1 2025 total prescriptions (TRx) increased 14% compared to Q1 2024Fanapt® Q1 2025 new to brand prescriptions (NBRx) increased nearly threefold compared to Q1 2024Bysanti™ (milsaperidone) NDA for bipolar I disorder and schizophrenia accepted for filing; PDUFA target action date of February 21, 2026Tradipitant NDA for motion sickness accep...
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05.05.2025
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Vanda Announces Bysanti™ NDA Filing; FDA Decision Expected in Early 2026
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WASHINGTON, May 5, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) informed Vanda that the New Drug Application (NDA) for Bysanti™ (milsaperidone) has been filed, and that at this time no potential review issues have been identified. The FDA has set February 2...
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02.05.2025
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Vanda Pharmaceuticals to Announce First Quarter 2025 Financial Results on May 7, 2025
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WASHINGTON, May 2, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the first quarter 2025 on Wednesday, May 7, 2025, after the market closes....
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23.04.2025
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FDA Bureaucrats Unlawfully Delay Hearing on Vanda Drug and Falsely Blame Commissioner Makary and the reductions in force at FDA
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WASHINGTON, April 23, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. ("Vanda") (Nasdaq: VNDA) today announced that FDA bureaucrats have committed to delay Vanda's request for a hearing on the approvability of tradipitant for gastroparesis. Rather than take accountability, FDA bureaucrats identify a new scapegoat: newly appointed Commissioner, Dr...
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07.04.2025
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Vanda Pharmaceuticals Announces Presentation at 2025 AAN Annual Meeting
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WASHINGTON, April 7, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced participation at the American Academy of Neurology (AAN) Annual Meeting, to be held in San Diego, California from April 5 through April 9, 2025. ...
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31.03.2025
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Vanda Pharmaceuticals Announces the Submission of an NDA to the FDA for Bysanti™ for the Treatments of Acute Bipolar I Disorder and Schizophrenia
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WASHINGTON, March 31, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) requesting marketing approval of Bysanti™ (milsaperidone) for the treatments of acute bipolar I disorder and schizophrenia. The NDA is supported...
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24.02.2025
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Vanda Pharmaceuticals announces the publication of an article titled "Potential ASO-based personalized treatment for Charcot-Marie-Tooth disease type 2S"
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WASHINGTON, Feb. 24, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the publication of an article entitled "Potential ASO-based personalized treatment for Charcot-Marie-Tooth disease type 2S" in Molecular Therapy Nucleic Acids1, a Cell Press partner journal, that describes the development of a novel antisen...
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05.02.2025
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Vanda Pharmaceuticals to Announce Fourth Quarter and Full Year 2024 Financial Results on February 13, 2025
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WASHINGTON, Feb. 5, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the fourth quarter and full year 2024 on Thursday, February 13, 2025, after the market closes. ...
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03.02.2025
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Vanda Pharmaceuticals and Anaptys Announce Exclusive Global License Agreement for Vanda to Develop and Commercialize Imsidolimab, an IL-36R Antagonist
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Imsidolimab has successfully completed two global Phase 3 studies in Generalized Pustular PsoriasisVanda expects to immediately begin preparing BLA and MAA applications for the US and EUAnaptys to receive $15 million from Vanda, comprised of a $10 million upfront payment and $5 million for existing drug supplyAnaptys to receive a 10% royalty on g...
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27.01.2025
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Vanda Pharmaceuticals Accepts FDA Opportunity for a Hearing on New Drug Application for Tradipitant in Gastroparesis
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Highlights faulty FDA reviewWASHINGTON, Jan. 27, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today provides an update on the tradipitant development program.
Gastroparesis is a serious digestive disorder...
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08.01.2025
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Vanda's Letter to FDA Commissioner Highlights Faulty Gastroparesis NDA Review
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WASHINGTON, Jan. 8, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) letter to FDA Commissioner highlights faulty gastroparesis NDA review.
As previously reported, Vanda has sought approval from the U.S. Food...
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20.12.2024
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Vanda Pharmaceuticals Announces Orphan Drug Designation Granted for VGT-1849A, a Novel and Selective Antisense Oligonucleotide Candidate for the Treatment of Polycythemia Vera
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WASHINGTON, Dec. 20, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for VGT-1849A, a selective antisense oligonucleotide (ASO)-based JAK2 inhibitor for the treatment of polycythemia vera (PV), a form of a rare hematologic malign...
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17.12.2024
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Glancy Prongay & Murray LLP Announces Investigation of Vanda Pharmaceuticals Inc.
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Glancy Prongay & Murray LLP (“GPM”) announces its investigation of Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) concerning the Company and its directors’ and officers’ possible violations of state laws.
If you own Vanda Pharmaceuticals stock, would like to learn more about these claims, or have any questions concerning this announcement or your...
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12.11.2024
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Vanda Pharmaceuticals Announces Participation at November 2024 Investor Conferences
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WASHINGTON, Nov. 12, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the following upcoming investor conferences in November 2024:
The Stifel 2024 Healthca...
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06.11.2024
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Vanda Pharmaceuticals Reports Third Quarter 2024 Financial Results
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Revenues for Q3 2024 were $47.7 million, an increase of 23% compared to Q3 2023Financial Guidance revised for Full Year 2024, raising the midpoint of revenue and cash rangesFanapt® launch in bipolar I disorder; new patient starts increased by over 90% in Q3 2024 as compared to Q3 2023Fanapt® long acting injectable program expected to be initiated...
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30.10.2024
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Vanda Pharmaceuticals to Announce Third Quarter 2024 Financial Results on November 6, 2024
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WASHINGTON, Oct. 30, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the third quarter 2024 on Wednesday, November 6, 2024, after the market closes....
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14.10.2024
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Vanda Pharmaceuticals Confirms Receipt of Economically Identical Unsolicited, Non-Binding Proposal from Cycle Group Holdings Ltd.
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Board Has Determined That Latest Proposal Is Not in the Best Interests of the Company or Stockholders
WASHINGTON, Oct. 14, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (Nasdaq: VNDA) today confirmed that it received a second unsolicited, non-binding proposal from Cycle Group Holdings Ltd. ("Cycle Group") to acquire t...
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19.09.2024
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FDA Declines to Approve Vanda's Marketing Application for Tradipitant in Gastroparesis
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WASHINGTON, Sept. 19, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today provided an update on its tradipitant development program.
On September 18, 2024, the U.S. Food and Drug Administration (FDA) declin...
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11.09.2024
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Vanda Pharmaceuticals Announces Participation in the 2024 Cantor Global Healthcare Conference
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WASHINGTON, Sept. 11, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the 2024 Cantor Global Healthcare Conference in New York City on Thursday, September 19, 2024. A fireside chat is scheduled for 8:00 a.m. Eastern Time....
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04.09.2024
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Vanda Pharmaceuticals Announces Participation in the H.C. Wainwright Global Investment Conference
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WASHINGTON, Sept. 4, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the H.C. Wainwright Global Investment Conference in New York City on Tuesday, September 10, 2024. A corporate presentation is scheduled for 2:00 p.m. Eastern Time....
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29.08.2024
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Vanda Pharmaceuticals Announces Participation in the Wells Fargo 2024 Healthcare Conference
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WASHINGTON, Aug. 29, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the Wells Fargo 2024 Healthcare Conference in Boston on Friday, September 6, 2024. A corporate presentation is scheduled for 11:00 a.m. Eastern Time....
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