Two Akin attorneys review a 3/9 FDA draft guidance recommending ways in which it would like to see human and drug manufacturers respond to form FDA-48...
FDA sends Aldeyra a complete response letter for its investigational dry eye treatment reproxalap, concluding that the company failed to provide suffi...
FDA extends by three months its review of a Lantheus Holdings NDA for LNTH-2501, a diagnostic imaging agent targeting neuroendocrine tumors.
A group of U.S. senators is pressing HHS to reverse recent changes to FDA and other federal health Web sites, warning that altered guidance on vaccine...
FDA inspectors cite multiple manufacturing and quality control deficiencies at a Gland Chemicals Private Limited in Chennai, India, manufacturing faci...
FDA updates an internal policy document outlining how CBER staff process supplements to approved drug and biologic applications.
NRx Pharmaceuticals says FDA has indicated it is willing to review a potential NDA for its investigational therapy NRX-100 without requiring additiona...
FDA has told NovaBridge Biosciences that its investigational cancer therapy givastomig could be eligible for an accelerated approval pathway following...
