food and drug administration

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

January 8, 2026

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

HHealthcare

BioXcel Therapeutics Announces Database Lock in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia

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 23, 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,…

HHealthcare

New blood tests for multiple cancers gain political backing

December 5, 2025

Dec. 2 (UPI) — As a new blood tests capable of detecting dozens of cancers in their early…

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MannKind Provides Update on Phase 3 ICoN-1 Trial of Nebulized Clofazimine for NTM Lung 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…

HHealthcare

Health-Care Earnings Top S&P 500 on Strong Drug, Hospital Demand

November 30, 2025

The largest American public health-care companies outperformed other industries in the third quarter, as higher new and specialty…

HHealthcare

Eli Lilly and Novo Nordisk May Soon Sell Weight Loss Drugs on the Planned TrumpRx. Could This Further Boost the Healthcare Giants' Stocks?

November 17, 2025

Don’t look now, but the costs of America’s beloved weight loss drugs are about to come down. Way…

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

New blood tests for multiple cancers gain political backing

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

Health-Care Earnings Top S&P 500 on Strong Drug, Hospital Demand

Eli Lilly and Novo Nordisk May Soon Sell Weight Loss Drugs on the Planned TrumpRx. Could This Further Boost the Healthcare Giants’ Stocks?