US FDA to limit regulation of health and fitness wearables, commissioner says
By Puyaan Singh Jan 6 (Reuters) – The U.S. Food and Drug Administration said on Tuesday that it…
BioXcel Therapeutics Planning to Submit sNDA This Month Seeking FDA Approval for At-Home Use of IGALMI®
BioXcel Therapeutics Company remains focused on potential approval and launch of IGALMI® for the acute treatment of agitation…
US FDA declines to approve Corcept’s drug for rare hormonal disorder
By Sneha S K and Sahil Pandey Dec 31 (Reuters) – The U.S. Food and Drug Administration has…
Vanda Jumps 21% After FDA Approves Motion Sickness Therapy
This article first appeared on GuruFocus. Vanda Pharmaceuticals (NASDAQ:VNDA) jumped roughly 21% in premarket trading after the U.S.…
Corcept Receives Complete Response Letter for Relacorilant as a Treatment for Patients with Hypercortisolism
REDWOOD CITY, Calif., December 31, 2025–(BUSINESS WIRE)–Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery…
Aptar’s Bidose Nasal System Delivers CARDAMYST™ (etripamil), the First and Only Self-Administered FDA-Approved Nasal Spray for Paroxysmal Supraventricular Tachycardia (PSVT)
Milestone Pharmaceuticals received U.S. Food and Drug Administration approval of CARDAMYST for the conversion of acute symptomatic episodes…
FDA OKs libido-boosting pill for older women who have gone through menopause
WASHINGTON (AP) — U.S. health officials have expanded approval of a much-debated drug aimed at boosting female libido,…
New blood tests for multiple cancers gain political backing
Dec. 2 (UPI) — As a new blood tests capable of detecting dozens of cancers in their early…
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
MannKind If approved, ReadyFlow Autoinjector would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/ml) in under…
Eli Lilly Trims Price of Popular Weight-Loss Drug on Its Site a Month After Trump Deal
Shelby Knowles / Bloomberg / Getty Images Eli Lilly shares have added over a third of their value…
Health-Care Earnings Top S&P 500 on Strong Drug, Hospital Demand
The largest American public health-care companies outperformed other industries in the third quarter, as higher new and specialty…
Vanda Pharmaceuticals Provides Regulatory Update on Tradipitant for Motion Sickness
FDA requests, and Vanda agrees to, a brief extension (to December 5, 2025) for the expedited re-review of…