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FDA Urges Companies to be ‘Recall Ready’ to Protect Public Health as Part of Final Guidance for Voluntary Recalls

The U.S. Food and Drug Administration finalized guidance to help companies prepare to quickly and effectively remove violative products from the market. The guidance...

Amnio Technology Launches Two New Dual-Layer Allografts.

Amnio Technology, a global leader in the development of and distribution of amniotic tissue allografts is announcing the launch of two new PalinGen membrane...

FDA Sodium Reduction Efforts Underscored in USDA’s Transitional Nutrition Standards for School Meals

One of the U.S. Food and Drug Administration's top priorities is to improve the health of Americans through better nutrition. We are pleased to...

Inspira Technologies Has Listed an FDA Class I 510(k) Exempt component of the ART system

Inspira Technologies OXY B.H.N. Ltd.  (the "Company" or "Inspira Technologies"), a groundbreaking respiratory support technology company, announced that has listed a component of its...

CTB001, Bioheng auto CAR – T Product, received Orphan Drug Designation (ODD) from the U.S. FDA

Recently, Nanjing Bioheng Biotech Co., Ltd. ( hereinafter referred to as Bioheng) announced that its anti-claudin 18.2 autologous CAR-T cell therapy product CTB001 received Orphan Drug Designation...
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