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The 'Press Releases' section offers the latest product-specific and company-related updates to our esteemed clients, providing them with a valuable resource. Members can leverage this platform for quick, efficient, and effective visibility.

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MIUDELLA® (copper intrauterine system)

Sebela Women's Health Inc. Announces FDA Approval of MIUDELLA®, the First Hormone-Free Copper Intrauterine System (IUS) in the U.S. in Over 40 Years

Sebela Women's Health Inc., a part of Sebela Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) granted approval of MIUDELLA®  (copper intrauterine system) for the prevention of pregnancy in females of reproductive potential for up to three years. MIUDELLA is a next-generation, hormone-free, low-dose copper intrauterine device or IUD, the first to be approved by the FDA in the United States in over 40 years.

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JOURNAVX bottle and tablet

Vertex announces FDA approval of JOURNAVX™ (suzetrigine), a first-in-class treatment for adults with moderate-to-severe acute pain

Vertex Pharmaceuticals Incorporated announced that the U.S. Food and Drug Administration (FDA) has approved JOURNAVX™ (suzetrigine), an oral, non-opioid, highly selective NaV1.8 pain signal inhibitor for the treatment of adults with moderate-to-severe acute pain. JOURNAVX is an effective, well-tolerated medicine without evidence of addictive potential indicated for use across all types of moderate-to-severe acute pain.

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Beckman Coulter’s Access p‑Tau217/β-Amyloid 1-42 plasma ratio Test.

Beckman Coulter receives FDA breakthrough device designation for a blood test for Alzheimer's disease

Beckman Coulter Diagnostics, a global leader in clinical diagnostics, announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Beckman Coulter's Access p‑Tau217/β-Amyloid 1-42 plasma ratio. This blood test is designed to aid healthcare providers identify patients with amyloid pathology associated with Alzheimer's disease.

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 SN BioScience

SN BioScience receives FDA IND clearance to propel SNB-101 into Phase 2

SN BioScience announced that its lead asset SNB-101 has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for a Phase 1b/2 clinical trial. This achievement follows the designation of SNB-101 as an orphan drug for small cell lung cancer in 2023 and its Fast Track designation in 2024.

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