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Browsing Tag

food and drug administration

56 posts
HHealthcare
BioXcel Therapeutics Announces Positive FDA Pre-sNDA Meeting Comments for sNDA Submission for BXCL501 in Agitation Associated with Bipolar Disorders or Schizophrenia
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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…
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

  • January 2, 2026
By Sneha S K and Sahil Pandey Dec 31 (Reuters) – The U.S. Food and Drug Administration has…
MMedication
GuruFocus.com
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Vanda Jumps 21% After FDA Approves Motion Sickness Therapy

  • December 31, 2025
This article first appeared on GuruFocus. Vanda Pharmaceuticals (NASDAQ:VNDA) jumped roughly 21% in premarket trading after the U.S.…
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

  • December 31, 2025
REDWOOD CITY, Calif., December 31, 2025–(BUSINESS WIRE)–Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery…
MMedication
Aptar’s Bidose Nasal System Delivers CARDAMYST™ (etripamil), the First and Only Self-Administered FDA-Approved Nasal Spray for Paroxysmal Supraventricular Tachycardia (PSVT)
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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…
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

  • December 15, 2025
WASHINGTON (AP) — U.S. health officials have expanded approval of a much-debated drug aimed at boosting female libido,…
HHealthcare
Yahoo news home
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FDA recalling blood pressure medication used by thousands: Is your medicine affected?

  • December 10, 2025
Check your medicine cabinets. More than 11,100 bottles of a type of blood pressure medication sold under the…
MMedication
The Independent
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US recalls popular blood pressure medication over fears of cross-contamination with another drug

  • December 10, 2025
A commonly used blood pressure medication has been recalled over fears that it may be cross-contaminated with another…
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 ReadyFlowâ„¢ 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…
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

  • December 2, 2025
Shelby Knowles / Bloomberg / Getty Images Eli Lilly shares have added over a third of their value…
HHealthcare
Eli Lilly and Novo Nordisk May Soon Sell Weight Loss Drugs on the Planned TrumpRx. Could This Further Boost the Healthcare Giants' Stocks?
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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…
HHealthcare
European Obesity Stocks Join Healthcare Rally as AI Trade Ebbs
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European Obesity Stocks Join Healthcare Rally as AI Trade Ebbs

  • November 14, 2025
European weight-loss drug developers have staged something of a comeback this week, as investors rotate into healthcare from…
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