FDA

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

KISMA Raises Alarms Over Fresh MSR, Seeks NCISM’s Exemption for Current Colleges from Guidelines

The Kerala-based Consortium of Self-Financing Ayurveda Institutions (KISMA) has voiced unease regarding the updated regulations set by the National Commission for Indian System of Medicine (NCISM). These revisions aim to oversee and standardize the essential criteria for academic institutions and

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Exploring Enhanced Venezuela-India Pharmaceutical Collaboration with Emphasis on Quality Control and Trade Barriers

In a major effort to boost pharmaceutical trade ties between India and Venezuela, a recent webinar delved into the hurdles and possibilities for increasing Indian pharmaceutical exports to Venezuela. This event, attended by crucial industry stakeholders, was co-hosted by the

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Lipella Pharma finishes dosing first cohort in phase 2a study of LP-310 for oral lichen planus treatment

Lipella Pharmaceuticals Inc., a biopharmaceutical company dedicated to pioneering treatments for serious ailments with significant unmet clinical needs, announced the conclusion of dosing for the initial cohort in its phase 2a multi-site clinical study of LP-310. LP-310 is a liposomal-tacrolimus

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CapeStart Launches MadeAi: An AI-Driven Platform Revolutionizing Life Science Literature Review

During the ISPOR Europe 2024 Conference, CapeStart, Inc. launched MadeAi, a platform powered by generative AI, designed to significantly optimize the consolidation of clinical data. Its first application, MadeAi-LR, redefines the efficiency of literature reviews, assisting systematic literature reviews (SLRs),

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China’s NMPA Greenlights Merck’s Welireg for Adult Von Hippel-Lindau-Related Tumors

Merck, recognized globally as MSD outside the Americas, has announced that China’s National Medical Products Administration (NMPA) has granted approval for Welireg (belzutifan) to be used in adult patients with von Hippel-Lindau (VHL) disease who need treatment for associated tumors

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