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FDA issues a complete response letter for Zealands glepaglutide intended to treat short bowel syndrome.[ Price : $8.95]
FDA warns a Viatris Mylan drug manufacturing facility in Pradesh, India, about CGMP violations involving quality and data issues.[ Price : $8.95]
FDA adds a liver injury Boxed Warning to labeling for Astellas menopause hot flash drug Veozah.[ Price : $8.95]
Lexicon stops development of its diabetes drug Zynquista that received an FDA complete response letter.[ Price : $8.95]
After receiving a complete response letter, Lykos Therapeutics says it will pursue FDAs dispute resolution process to question the...[ Price : $8.95]
Reed Smith attorney James Beck says companies hit by FDA for off-label promotion may challenge the agencys reasoning under the new...[ Price : $8.95]
FDA extends by three months its review of a Syndax Pharmaceuticals NDA for revumenib and its use in treating adult and pediatric p...[ Price : $8.95]
A detailed FDLI analysis looks at how expected Supreme Court changes to the Chevron federal agency deference principle will likely...