L&S Research receives FDA warning letter for Super Water Pill Caplets, Fusion Multi-Power Tablets, Cyberblast Capsules, Super Fat-Loss Tablets, QuickTrim Complex #1-#4 Caplets, CyberTrim Formulas #1-#4 Tablets, Mega-Fat Burner Tablets, Protabalase (EM and ME formulas) and Palm Springs Elite Total Diet Plan (AM and PM formulas). FDA stated that labeling and promotional materials for the items indicate that they are unapproved new drugs. FDA asked L&S to provide its "intentions for the continued promotion and marketing of these products as OTC weight control drug products"
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
