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Browsing Tag

Food and Drug Administration

28 posts
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Vanda Pharmaceuticals Provides Regulatory Update on Tradipitant for Motion Sickness
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Vanda Pharmaceuticals Announces Receipt of FDA Decision Letter on HETLIOZ® Supplemental New Drug Application for Jet Lag Disorder

  • 8 January 2026
WASHINGTON, Jan. 8, 2026 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has received…
HHealthcare
BioXcel Therapeutics Planning to Submit sNDA This Month Seeking FDA Approval for At-Home Use of IGALMI®
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BioXcel Therapeutics Planning to Submit sNDA This Month Seeking FDA Approval for At-Home Use of IGALMI®

  • 7 January 2026
BioXcel Therapeutics Company remains focused on potential approval and launch of IGALMI® for the acute treatment of agitation…
MMedication
US FDA declines to approve Corcept's drug for rare hormonal disorder
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US FDA declines to approve Corcept’s drug for rare hormonal disorder

  • 2 January 2026
By Sneha S K and Sahil Pandey Dec 31 (Reuters) – The U.S. Food and Drug Administration has…
MMedication
Corcept Receives Complete Response Letter for Relacorilant as a Treatment for Patients with Hypercortisolism
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Corcept Receives Complete Response Letter for Relacorilant as a Treatment for Patients with Hypercortisolism

  • 1 January 2026
REDWOOD CITY, Calif., December 31, 2025–(BUSINESS WIRE)–Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery…
MMedication
GuruFocus.com
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Vanda Jumps 21% After FDA Approves Motion Sickness Therapy

  • 31 December 2025
This article first appeared on GuruFocus. Vanda Pharmaceuticals (NASDAQ:VNDA) jumped roughly 21% in premarket trading after the U.S.…
MMedication
FDA OKs libido-boosting pill for older women who have gone through menopause
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FDA OKs libido-boosting pill for older women who have gone through menopause

  • 15 December 2025
WASHINGTON (AP) — U.S. health officials have expanded approval of a much-debated drug aimed at boosting female libido,…
MMedication
Eli Lilly Trims Price of Popular Weight-Loss Drug on Its Site a Month After Trump Deal
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Eli Lilly Trims Price of Popular Weight-Loss Drug on Its Site a Month After Trump Deal

  • 2 December 2025
Shelby Knowles / Bloomberg / Getty Images Eli Lilly shares have added over a third of their value…
MMedication
MannKind Provides Update on Phase 3 ICoN-1 Trial of Nebulized Clofazimine for NTM Lung Disease
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MannKind Announces U.S. FDA Accepts for Review its Supplemental New Drug Application (sNDA) of FUROSCIX ReadyFlow™ Autoinjector for the Treatment of Edema in Adults with Chronic Heart Failure or Chronic Kidney Disease

  • 2 December 2025
MannKind If approved, ReadyFlow Autoinjector would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/ml) in under…
MMedication
Vanda Pharmaceuticals Provides Regulatory Update on Tradipitant for Motion Sickness
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Vanda Pharmaceuticals Provides Regulatory Update on Tradipitant for Motion Sickness

  • 29 November 2025
FDA requests, and Vanda agrees to, a brief extension (to December 5, 2025) for the expedited re-review of…
MMedication
FDA's plan to boost cheaper copycat drugs could stall at the patent office
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FDA’s plan to boost cheaper copycat drugs could stall at the patent office

  • 15 November 2025
While the FDA is streamlining regulation of copycat versions of the expensive drugs that millions take for arthritis,…
United Kingdom
www.europesays.com