FDA

News and Updates by the Food and Drugs Administration (FDA)

Insights Reveal Advantages of da Vinci Robotic Surgery Across Seven Cancer Procedures

**Intuitive Surgical** (Nasdaq:ISRG) unveiled results from a comprehensive analysis of surgical results spanning various robotic operations. The prestigious Annals of Surgery has published a thorough examination of surgical outcomes over a 30-day period across seven cancer-related surgeries. This analysis compared

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EpicentRx’s AdAPT-001 Receives US FDA Fast Track Status for Advanced Soft Tissue Sarcoma Treatment

EpicentRx, a privately-operated biopharmaceutical entity, has disclosed that their investigational therapy, AdAPT-001, has been awarded a Fast Track designation by the US Food and Drug Administration. AdAPT-001, combined with immune checkpoint inhibitors like nivolumab or atezolizumab, targets the treatment of

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Cambrex Collaborates with Lilly to Enhance Biotech Partner Manufacturing Efforts

Cambrex, a prominent global contract development and manufacturing organization (CDMO), has announced a new partnership with Eli Lilly and Company (Lilly) to facilitate speedy access to clinical development resources for Lilly’s biotech partners. In this collaboration, Cambrex will join forces

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Merck and Ridgeback Biotherapeutics Launch Phase 3 Trial for Covid-19 Treatment Lagevrio in High-Risk Adults

Global pharmaceutical company Merck, also referred to as MSD outside the US and Canada, has launched the phase 3 MOVe-NOW clinical trial. The trial aims to assess the effectiveness of Lagevrio (molnupiravir), an investigative oral antiviral medication, in treating Covid-19

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Study by NIH Highlights Significance of Prevention & Screening in Reducing Deaths from Five Major Cancers

A study spearheaded by the National Institutes of Health (NIH) has demonstrated that progress in cancer prevention and screening has significantly reduced mortality rates in five common cancer types over the last 45 years, surpassing the impact of advancements in

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Phase IIIB Study Reveals Novartis’ Fabhalta Enhances Haemoglobin in Adult PNH Patients Transitioned from Anti-C5 Treatment

Novartis has shared favorable initial findings from the APPULSE-PNH study, a Phase IIIB trial that assesses the effectiveness and safety of the twice-daily oral drug Fabhalta (iptacopan) for adults with paroxysmal nocturnal hemoglobinuria (PNH) who previously underwent anti-C5 therapies. Post

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AstraZeneca’s Imfinzi Granted Priority Review by US FDA for Treating Muscle-Invasive Bladder Cancer

The United States Food and Drug Administration has accepted AstraZeneca’s supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab), providing it Priority Review status for muscle-invasive bladder cancer (MIBC) treatment. The FDA assigns Priority Review to drug applications that, if approved,

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