FDA Related News

Medical Devices

Medtronic Renal System Lowered Blood Pressure: Trial

Medtronic says a clinical trial showed that patients who were prescribed anti-hypertensive medications and treated with its Symplicity Spyral Renal De...

Human Drugs

FDA OKs Igalmi for Schizophrenia/Bipolar Agitation

FDA approves a BioXcel Therapeutics NDA for Igalmi (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophreni...

Biologics

FDA to Decide in June on Next Booster Compostion

FDA officials say that a decision will likely be made in June on whether a new Covid-19 booster composition is needed by November in time for any wint...

Human Drugs

Comments on Presser Assessment Guidance

Six drug companies comment on an FDA draft guidance on assessing drug presser effects.

Human Drugs

FDA Lists 6 OMB-approved Info Collections

Federal Register notice: FDA announces that six information collections that have been approved by OMB.

Human Drugs

FDA to Rate Drug Firms Quality Management Maturity

A new FDA whitepaper outlines the agencys plans to advance a framework to objectively rate pharmaceutical manufacturing sites Quality Management Matur...

Human Drugs

Priority Review for Dupixent sBLA

FDA grants priority review for Sanofi and Regenerons sBLA for a new Dupixent indication.

Human Drugs

Novartis Gene Therapy Facility Approved by FDA

FDA gives commercial licensure approval to a second Novartis gene therapy manufacturing facility, this one in Durham, NC.

FDA Participating in EHR Integration Project

FDA participates in the OneSource electronic health record data integration project.

Human Drugs

Sotrovimab No Longer Authorized Anywhere

FDA says GlaxoSmithKlines sotrovimab is now not authorized for use in any HHS region because the proportion of Covid-19 cases from the omicron BA.2 su...