food and drug administration

Vanda Pharmaceuticals Provides Regulatory Update on Tradipitant for Motion Sickness

January 8, 2026

WASHINGTON, Jan. 8, 2026 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has received…

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BioXcel Therapeutics Planning to Submit sNDA This Month Seeking FDA Approval for At-Home Use of IGALMI®

January 7, 2026

BioXcel Therapeutics Company remains focused on potential approval and launch of IGALMI® for the acute treatment of agitation…

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US FDA declines to approve Corcept's drug for rare hormonal disorder

January 2, 2026

By Sneha S K and Sahil Pandey Dec 31 (Reuters) – The U.S. Food and Drug Administration has…

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December 31, 2025

This article first appeared on GuruFocus. Vanda Pharmaceuticals (NASDAQ:VNDA) jumped roughly 21% in premarket trading after the U.S.…

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Corcept Receives Complete Response Letter for Relacorilant as a Treatment for Patients with Hypercortisolism

December 31, 2025

REDWOOD CITY, Calif., December 31, 2025–(BUSINESS WIRE)–Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery…

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Aptar’s Bidose Nasal System Delivers CARDAMYST™ (etripamil), the First and Only Self-Administered FDA-Approved Nasal Spray for Paroxysmal Supraventricular Tachycardia (PSVT)

December 19, 2025

Milestone Pharmaceuticals received U.S. Food and Drug Administration approval of CARDAMYST for the conversion of acute symptomatic episodes…

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FDA OKs libido-boosting pill for older women who have gone through menopause

December 15, 2025

WASHINGTON (AP) — U.S. health officials have expanded approval of a much-debated drug aimed at boosting female libido,…

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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

December 2, 2025

MannKind If approved, ReadyFlow Autoinjector would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/ml) in under…

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Eli Lilly Trims Price of Popular Weight-Loss Drug on Its Site a Month After Trump Deal

December 2, 2025

Shelby Knowles / Bloomberg / Getty Images Eli Lilly shares have added over a third of their value…

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November 29, 2025

FDA requests, and Vanda agrees to, a brief extension (to December 5, 2025) for the expedited re-review of…

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FDA's plan to boost cheaper copycat drugs could stall at the patent office

November 15, 2025

While the FDA is streamlining regulation of copycat versions of the expensive drugs that millions take for arthritis,…

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580K bottles of blood pressure medications recalled due to cancer-causing chemical – WSB-TV Channel 2

November 3, 2025

More than half a million bottles of a popular blood pressure medication have been recalled because they contain…

Vanda Pharmaceuticals Announces Receipt of FDA Decision Letter on HETLIOZ® Supplemental New Drug Application for Jet Lag Disorder

BioXcel Therapeutics Planning to Submit sNDA This Month Seeking FDA Approval for At-Home Use of IGALMI®

US FDA declines to approve Corcept’s drug for rare hormonal disorder

Vanda Jumps 21% After FDA Approves Motion Sickness Therapy

Corcept Receives Complete Response Letter for Relacorilant as a Treatment for Patients with Hypercortisolism

Aptar’s Bidose Nasal System Delivers CARDAMYST™ (etripamil), the First and Only Self-Administered FDA-Approved Nasal Spray for Paroxysmal Supraventricular Tachycardia (PSVT)

FDA OKs libido-boosting pill for older women who have gone through menopause

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

Eli Lilly Trims Price of Popular Weight-Loss Drug on Its Site a Month After Trump Deal

Vanda Pharmaceuticals Provides Regulatory Update on Tradipitant for Motion Sickness

FDA’s plan to boost cheaper copycat drugs could stall at the patent office

580K bottles of blood pressure medications recalled due to cancer-causing chemical – WSB-TV Channel 2