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A biopharmaceutical expert petitions FDA to establish a risk-based regulatory framework for peptide therapeutics.[ Price : $8.95]
At a 12/11/2025 MDUFA 6 reauthorization meeting, FDA presented its views on changes involving using real-world evidence and calcul...[ Price : $8.95]
FDA releases the form FDA-483 with nine observations from an inspection at Greeces Pharmathen International.[ Price : $8.95]
FDA issues a complete response letter to Outlook Therapeutics seeking additional confirmatory evidence for its BLA for Lytenava to...[ Price : $8.95]
FDA grants priority review for an Axsome Therapeutics sNDA to treat Alzheimers disease agitation.[ Price : $8.95]
Two lengthy news service stories raise questions about FDAs approach to vaccines being espoused by CDER director Tracy Beth Heg an...[ Price : $8.95]
FDA issues a complete response letter to Sanofis NDA for tolebrutinib to treat non-relapsing secondary progressive multiple sclero...[ Price : $8.95]
An inspection of a Dr. Reddy's India manufacturing plant raises significant GMP issues in a new Form FDA 483.