FDA

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

EMA Grants PRIME Status to GSK’s B7-H3-directed ADC, GSK’227, for Recurrent Extensive-stage SCLC

GSK plc has revealed that the European Medicines Agency (EMA) has awarded Priority Medicines (PRIME) status to GSK5764227 (GSK’227), a B7-H3-aimed antibody-drug conjugate (ADC) undergoing trials for patients with recurrent extensive-stage small-cell lung cancer (ES-SCLC). The PRIME Designation facilitates the […]

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Innovent Biologics and Eli Lilly Expand Partnership to Bring BTK Inhibitor Jaypirca to Mainland China

Innovent Biologics, a prominent biopharmaceutical company, and Eli Lilly and Company have jointly announced a Distribution and Promotion Agreement focused on introducing Lilly’s reversible BTK inhibitor, Jaypirca, to Mainland China. This partnership entails Innovent taking charge of importing, marketing, distributing,

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Bavarian Nordic Partners with Serum Institute of India for MVA-BN Mpox Vaccine Manufacturing and Licensing

Bavarian Nordic A/S, a worldwide leader in vaccine innovation aimed at improving health and saving lives, has struck a licensing and production deal with Serum Institute of India Pvt. Ltd. (SII) to manufacture its MVA-BN mpox vaccine. This collaboration involves

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FDA Bestows Breakthrough Status to GSK’s Jemperli for Advanced Rectal Cancer with dMMR/MSI-H Markers

GSK plc has disclosed that the United States Food and Drug Administration (FDA) has awarded Breakthrough Therapy Designation to Jemperli (dostarlimab) for patients dealing with locally advanced mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) rectal cancer. The Breakthrough Therapy

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Ministry of Ayush to Introduce National Pharmacovigilance Portal for ISM to Combat Misleading Ads

The Union Ministry of Ayush (MOA) is poised to unveil a national platform dedicated to pharmacovigilance within Indian Systems of Medicine (ISM), aiming to support the Ministry’s endeavors to curb misleading advertisements. This information was shared by Dr. Kousthubha Upadhyaya,

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Transformive Role of Healthtech in Preventive Healthcare and Workplace Wellness, by Shashank Avadhani

With businesses increasingly understanding that employee well-being is not solely an individual concern but a significant organizational responsibility, preventative healthcare is becoming a groundbreaking approach to boost sustained productivity and overall health. In this context, healthtech—where healthcare meets technology—is essential

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Metropolis Healthcare Launches Breakthrough Blood Collection Device Easing Pain and Anxiety

Ameera Shah’s Metropolis Healthcare Limited, renowned as India’s second-largest and highly esteemed pathology lab network, has launched the UltraTouch Push Button Blood Collection Set (PBBCS) throughout its branches. This cutting-edge tool incorporates a finer needle aimed at easing the pain

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