FDA Related News

Biologics

Rejuvenate Stem Cell Center Cautioned on Umbilical Stem Cells

CBER says Rejuvenate Stem Cell Center is marketing umbilical stem cells for a variety of diseases and conditions without an NDA or BLA.

Human Drugs

10 Observations in Hospira FDA-483

FDA releases the FDA-483 with 10 observations issued following an inspection six months ago at Hospiras sterile drug manufacturing facility in McPhers...

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.

Human Drugs

Lilly Employees Say Exec Rewrote FDA Reports

A Reuters exclusive report says Lilly employees have complained that an executive at the firms Branchburg, N.J., manufacturing facility for a Covid-19...

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.

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.