FDA

NEWS DESK

Fujirebio Submits FDA Regulatory Filing for Lumipulse

News Desk 1 26/09/2024

Fujirebio today announced that its wholly-owned subsidiary Fujirebio Diagnostics, Inc. has filed its Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test with the U.S. Food and Drug Administration (FDA). The new plasma test is expected to be the first

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Neuraptive Therapeutics Receives FDA Breakthrough Therapy Designation for NTX-001

News Desk 1 12/09/2024

Neuraptive Therapeutics, Inc. today announced that NTX-001 has been granted Breakthrough Therapy Designation, thus providing the potential for accelerated development for patients with peripheral nerve injury requiring repair. This designation follows the results from the Phase 2 NEUROFUSE study and several interactions with the FDA. NTX-001 has the potential to be a

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Guard Medical Announces FDA 510(k) Clearance for Additional Large Sizes of Its Novel NPseal® NPWT Surgical Dressing

News Desk 1 19/08/2024

Privately-held company Guard Medical Inc. today announces FDA 510(k) clearance for additional large sizes (surgical wounds up to 25cm) of its next generation Negative Pressure Wound Therapy (NPWT) dressing NPseal for the treatment of closed surgical incisions. NPseal is an easy-to-use, affordable, and cost-effective NPWT surgical

NEWS DESK

Accutar Biotechnology Receives FDA Fast Track Designation

News Desk 1 14/08/2024

Accutar Biotechnology, Inc., a biotechnology company focusing on artificial intelligence (AI)-enabled drug discovery, announced today that the US Food and Drug Administration (FDA) has granted the investigation of AC699 a Fast Track designation for the treatment of patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative,