Latest News and Press Releases

Want to stay updated on the latest news?

Sign into Reader Account Create Reader Account

July 24, 2026 06:30 ET | Source: MannKind

MannKind Announces FDA Approval of Furoscix ReadyFlow™, the First and Only Autoinjector Delivering IV-Equivalent Diuretic Therapy for the Treatment of Edema in Adults with Heart Failure or Chronic Kidney Disease

MannKind announces FDA approval of Furoscix ReadyFlow™, the first & only autoinjector delivering IV-equivalent diuretic therapy for the treatment of edema
July 22, 2026 15:10 ET | Source: Serenity Medical

Serenity Medical’s River Stent™ Demonstrates Sustained 4- to 5-Year Benefits in Patients with Idiopathic Intracranial Hypertension (IIH), Presented at SNIS Annual Meeting in Late-Breaking Session

MAPLE GROVE, Minn., July 22, 2026 (GLOBE NEWSWIRE) -- Serenity Medical, a NeuroTechnology Investors (NTI) portfolio company and pioneer in venous sinus stenosis treatment, today announced during a...
July 21, 2026 09:00 ET | Source: NeuroSigma, Inc.

NeuroSigma Announces U.S. Commercial Launch of Second-Generation Monarch® eTNS System for Pediatric ADHD

U.S. Commercial launch of Gen 2 Monarch System commencing today, July 21, 2026Gen 2 Monarch device provides an enhanced patient experience while delivering clinically proven therapeutic stimulation of...
July 20, 2026 09:00 ET | Source: Oncolytics Biotech, Inc.

Oncolytics Biotech® Receives Fast Track Designation for Pelareorep in Second-Line and Later Anal Cancer

Oncolytics announced the FDA has granted Fast Track designation to pelareorep in combination with a checkpoint inhibitor for squamous cell anal cancer.
July 17, 2026 15:14 ET | Source: FDA

FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol

Silver Spring, MD, July 17, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9...
July 16, 2026 04:58 ET | Source: Arletta Pharma Solutions

Arletta Pharma Solutions Receives FDA Response Supporting the Clinical Development Program of Lybrido™ for Female Sexual Interest/Arousal Disorder in the US

FDA endorses key elements of Arletta Pharma's Phase 2 study of Lybrido, a dual-action therapy for women with FSIAD/HSDD, and opens path to a single Phase 3
July 15, 2026 09:00 ET | Source: NeOnc Technologies Holdings, Inc.

NeOnc Receives FDA Written Feedback on NEO212 CMC Development and Capsule-to-Tablet Transition

NeOnc Receives FDA Written Feedback on NEO212 CMC Development and Capsule-to-Tablet Transition
July 13, 2026 09:00 ET | Source: Oncolytics Biotech, Inc.

Oncolytics Biotech® Reports FDA Regulatory Milestone and Strong Clinical Progress in Randomized RAS-Mutant MSS Colorectal Cancer Trial

Oncolytics announced more than 20 patients pre-identified for REO 033 colorectal cancer trial and scheduled Type D meeting with the FDA.
July 13, 2026 08:00 ET | Source: Claria Medical

FDA Grants De Novo Classification to Claria Medical for Device Designed to Improve Safety and Efficiency of Hysterectomy Procedures

FDA grants De Novo classification to Claria Medical for device designed to improve the safety and efficiency of hysterectomy procedures
July 10, 2026 12:30 ET | Source: Elevar Therapeutics

Elevar Therapeutics Receives FDA Complete Response Letter for Combination of Rivoceranib and Camrelizumab as a First-line Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

FORT LEE, N.J., July 10, 2026 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating...