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FDA completes inspection of Nexus’ manufacturing facility in US

Pharma Leaders

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. Nexus Pharmaceuticals stated that the regulatory approval process validates facilities’ compliance with stringent quality and safety standards.

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US FDA grants approval for Azurity’s Konvomep to treat gastric ulcer

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Azurity Pharmaceuticals’ Konvomep (omeprazole and sodium bicarbonate for oral suspension) to treat active benign gastric ulcer. A pharmaceutical firm, Azurity focuses on developing new products for the special requirements of overlooked patients.

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mRNA therapeutics: a limitless revolution in medicine

European Pharmaceutical Review

The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category” The term ‘mRNA’ has become commonplace globally. The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category.

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FDA Authorizes Marketing of MISHA™ Knee System for People Suffering from Knee Osteoarthritis

Legacy MEDSearch

Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. Chief, Hip and Knee Division of Sports Medicine Institute, Hospital for Special Surgery in New York.

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FDA Approves Innovative 4D Flow MRI Blood Flow Analysis Software from Cardio Flow Design Inc.

Legacy MEDSearch

The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis. The FDA approval of iTFlow® will enable healthcare professionals to make more precise and effective decisions in patient care. iTFlow® is an innovative software solution developed by Cardio Flow Design Inc. Dr. Itatani, MD, Ph.D.,

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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity” The focus until now has too often been on compliance and not on quality. Takeaways from ISPE’s GAMP 5 Second Edition update.

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Covid-19 Omicron boosters will reinvigorate injectables manufacturing

Pharmaceutical Technology

On 25 June, Pfizer and BioNTech (Mainz, Germany) reported pivotal Phase II/III data demonstrating the safety, tolerability and immunogenicity of two Omicron-adapted vaccine candidates. Australia’s Therapeutic Goods Administration (TGA) granted a provisional determination in April to Moderna’s Omicron jab, and in July to Pfizer’s Omicron jab.