FDA Related News

Human Drugs

FDA Extends Research with CN Bio for 3 Years

FDA extends for three years a research collaboration with CN Bio and broadens the scope to explore the firms lung-on-a-chip platform for evaluating in...

Human Drugs

Juno Therapeutics Inspection Report Released

FDA releases the establishment inspection report containing six observations from a 10/2020 inspection at Juno Therapeutics.

Human Drugs

FDA Questions Single Trial Adequacy for Avacopan

FDA reviewers question the adequacy of a single Phase 3 trial submitted to support a ChemoCentryx NDA for avacopan, indicated for treating adult patie...

Medical Devices

Genesis Shoulder Arthroplasty Software Cleared

FDA clears a Genesis Software Innovations 510(k) for its PreView 3D Shoulder Arthroplasty Planning Software.

Incyte Pays $12.6 Million Over Kickbacks

Incyte agrees to pay $12.6 million to resolve allegations that it violated the False Claims Act by paying kickbacks.

FDA General

FDA Scenarios for Future Inspections

FDA acting commissioner Janet Woodcock says the agency is developing various scenarios for moving back to standard inspection operations.

Human Drugs

Former CDER CV/Renal Deputy Joins NDA Partners

Former CDER Division of Cardiovascular and Renal Products deputy director Stephen Grant joins NDA Partners as an expert consultant.

Human Drugs

Otezla sNDA to Expand Plaque Psoriasis Indication

FDA accepts for review an Amgen supplemental NDA for Otezla (apremilast) for treating adults with mild-to-moderate plaque psoriasis.

Bipartisan Real-World Evidence Legislation Introduced

Sens. Marshall, Smith, and Cassidy introduce bipartisan legislation to enable FDA to develop a framework for using real-world evidence gathered from e...

Human Drugs

Pfizer Reports Elranatamab Hiccup on New Study

Pfizer pauses enrollment in a registration-enabling Phase 2 study of elranatamab after FDA requested additional data on three cases of peripheral neur...