FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Human Drugs

FDA OKs Losartan with NMBA Below 9.82 PPM

FDA says it is allowing temporary distribution of losartan with NMBA levels up to 9.82 ppm to ease a supply shortage.

Human Drugs

Amphastar ANDA Approved for Generic Lovenox Vials

FDA approves an Amphastar Pharmaceuticals ANDA for blood thinner enoxaparin sodium injection 300mg/3mL (100mg/mL) multiple dose vials, a generic copy ...

Federal Register

Guide on Pre-Exposure HIV Drug Development

Federal Register notice: FDA makes available a final guidance entitled Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for...

Human Drugs

J&J Agrees to End Forced Swim Tests

PETA says Johnson & Johnson has agreed to stop so-called forced swim tests of small animals as a means of determining effectiveness of drugs to treat ...

Human Drugs

CDER Top Drug Compounding Official Leaving Agency

CDER senior science advisor for compounding Julie Dohm resigns to join Covington & Burling, effective 3/29.

Medical Devices

FDA Warns 2 Breast Implant Makers on Studies

FDA warns two breast implant manufacturers about deficiencies in their mandated post-approval studies of device long-term safety and risks.

Human Drugs

Partial Hold on Abbvie/Roche Myeloma Trial

FDA places a partial clinical hold on an AbbVie and Roche clinical trial program for Venclexta/Venclyxto (venetoclax) for the investigational treatmen...

Human Drugs

Nutra Pharma Warned on Illegal Marketing

FDA sends a Warning Letter to Nutra Pharma for illegally marketing unapproved products labeled as homeopathic with claims for treating addiction and c...

Human Drugs

Mylan Recalls 2 Lots of Levoleucovorin Injection

Mylan recalls two lots of levoleucovorin injection, 250 mg/25 mL due to the presence of particulate matter that has been identified as copper salts.

Biologics

Genentech sBLA OKd for Tecentriq in Lung Cancer

FDA approves a Genentech sBLA for Tecentriq (atezolizumab) for combination use with carboplatin and etoposide for first-line treatment of adults with ...