FDA

NEWS DESK

Awiqli® approved in the US, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes

News Desk 30/03/2026

Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Awiqli® (insulin icodec-abae) injection 700 units/mL, the first and only once-weekly, long-acting basal insulin, indicated as an adjunct to diet and exercise to improve glycaemic control (blood sugar) in

NEWS DESK

Novo Nordisk A/S: Wegovy® HD (semaglutide 7.2 mg) approved in the US, providing 20.7% mean weight loss

News Desk 24/03/2026

Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Wegovy® HD (once-weekly injectable semaglutide 7.2 mg) to reduce excess body weight and maintain weight reduction long-term. The FDA awarded a Commissioner’s National Priority Voucher for Wegovy® HD, accelerating its review and underscoring its potential to address critical patient

NEWS DESK

LEO Pharma Announces FDA Approval of ANZUPGO® (delgocitinib) Cream in the U.S.

PR News Desk 25/07/2025

LEO Pharma, a global leader in medical dermatology, announced today that the U.S. Food and Drug Administration (FDA) has approved ANZUPGO® (delgocitinib) cream (20 mg/g) for the topical treatment of moderate-to-severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable.1 ANZUPGO is an

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FDA Approves Tirzepatideas the First and Only Prescription Medicine for Moderate-to-Severe Obstructive Sleep Apnea

PR News Desk 15/01/2025

The U.S. Food and Drug Administration (FDA) approved lately Tirzepatide, produced by Eli Lilly, as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. Tirzepatide may help adults with moderate-to-severe obstructive sleep apnea and obesity improve their sleep disorder. It should be used with a

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Fujirebio Submits FDA Regulatory Filing for Lumipulse

PR News Desk 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 commercially available blood-based IVD test in the U.S. to help in the

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Neuraptive Therapeutics Receives FDA Breakthrough Therapy Designation for NTX-001

PR News Desk 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

PR News Desk 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

PR News Desk 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,