FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Human Drugs

OIG Backs Manufacturer-Sponsored Patient Tests

Two Sheppard attorneys discuss an HHS Inspector General advisory opinion backing a drug companys arrangement with a third-party laboratory for free an...

latest-news-card-1
Biologics

Former CDC Official Alleges Political Interference In Vaccine Policy

During a CBS News interview, former CDC chief medical officer Debra Houry says she left the agency after concluding she could no longer defend its sci...

latest-news-card-1
FDA General

Insufficient Data on 7 Peptides for Potential Compounding Use: FDA

FDA briefing materials show that agency reviewers have found limited evidence supporting the safety and effectiveness of seven peptide substances that...

latest-news-card-1
Medical Devices

BMC Medical Selling Adulterated, Misbranded CPAPs: FDA

FDA warns Chinas BMC Medical that it is marketing adulterated and misbranded ventilators in the U.S. without an approved PMA in place for the devices....

latest-news-card-1
Human Drugs

FDA OKs Casgevy for Younger Children

FDA approves an expanded age indication for Vertex Pharmaceuticals sickle cell drug Casgevy.

latest-news-card-1
Medical Devices

Quality System, Other Violations at 3B Medical

FDA warns 3B Medical about multiple violations in its work manufacturing a software device used with ventilator systems imported from China.

Medical Devices

AseptiKits Marketing Adulterated, Misbranded Devices: FDA

FDA warns AseptiKits it is manufacturing and marketing adulterated and misbranded PALA Your Tears medical devices.

latest-news-card-1
Human Drugs

FDA Approves BESREMi Pen for Polycythemia Vera

FDA approves PharmaEssentias BESREMi injection pen to treat polycythemia vera.

latest-news-card-1
Human Drugs

FDA Declines to Approve Sobi Gout Therapy

FDA issues Sobi a Complete Response Letter on its BLA that is seeking approval of NASP (nanoencapsulated sirolimus plus pegadricase) for treating adul...

latest-news-card-1
Biologics

EC Opens Antitrust Probe into Sanofi's Flu Vaccine Marketing

The European Commission opens a formal antitrust investigation into whether Sanofi abused its dominant market position by allegedly conducting a misle...