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New Formulation for Alexions Ultomiris

[ Price : $8.95]

FDA approves Alexion Pharmaceuticals Ultomiris (ravulizumab-cwvz) 100 mg/mL, a new dosing formulation for treating adults with par...

FDA Clears GE Ultra Edition for Vivid Ultrasound

[ Price : $8.95]

FDA clears a GE Healthcare 510(k) for the Ultra Edition package on its Vivid cardiovascular ultrasound systems, which includes new...

Foresee Pharma NDA Accepted for Prostate Cancer

[ Price : $8.95]

FDA accepts for review a Foresee Pharmaceuticals 505(b)(2) NDA for Camcevi 42mg, a ready-to-use six-month depot formulation of leu...

Beckman EUA for Covid Immunoglobulin Assay

[ Price : $8.95]

FDA grants Beckman Coulter an emergency use authorization for its Access SARS-CoV-2 Immunoglobulin M (IgM) assay.

Revised FDA Procedure on ANDA Suitability Petitions

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FDA issues a revised Manual of Policies and Procedures on ANDA Suitability Petitions to clarify certain issues and include minor u...

FDA Withdraws 13 No-Longer-Marketed NDAs

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Federal Register notice: FDA withdraws approval of 13 NDAs from multiple applicants after they notified the agency that the drug p...

9 No-Longer-Marketed ANDAs Withdrawn

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Federal Register notice: FDA withdraws approval of nine ANDAs from multiple applicants after they notified the agency that the dru...

FDA Mulls Safety Signal on Intercepts Ocaliva

[ Price : $8.95]

FDA tells Intercept Pharmaceuticals that it is evaluating a newly identified safety signal regarding liver disorder for Ocaliva.

Griffo Botanicals Cited of Covid Product Claims

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FDA sends Griffo Botanicals (Petaluma, CA) a Warning Letter after reviewing the companys Web site and social media sites and deter...

FDA Should Improve Lab Safety Oversight: GAO

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The Government Accountability Office recommends five steps FDA should take to strengthen its oversight of safety in agency laborat...