FDA grants priority review for an Axsome Therapeutics sNDA to treat Alzheimers disease agitation.
Two lengthy news service stories raise questions about FDAs approach to vaccines being espoused by CDER director Tracy Beth Heg and CBER director Vina...
FDA issues a complete response letter to Sanofis NDA for tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis in adults.
An inspection of a Dr. Reddy's India manufacturing plant raises significant GMP issues in a new Form FDA 483.
Lawmakers introduce bipartisan legislation in the House and Senate to provide a skinny label safe harbor for certain human and animal drugs.
FDA warns Montague, MI-based Tower Laboratories about CGMP violations in its manufacture of finished drugs.
FDA warns Tampa, FL-based LiquidCapsule Manufacturing about repeated CGMP violations in its production of finished drugs.
FDA publishes digital health guidances relating to low-risk general wellness products and clinical decision support software.
