FDA approves an Amphastar Pharmaceuticals ANDA for blood thinner enoxaparin sodium injection 300mg/3mL (100mg/mL) multiple dose vials, a generic copy ...
Federal Register notice: FDA makes available a final guidance entitled Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for...
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 ...
CDER senior science advisor for compounding Julie Dohm resigns to join Covington & Burling, effective 3/29.
FDA warns two breast implant manufacturers about deficiencies in their mandated post-approval studies of device long-term safety and risks.
FDA places a partial clinical hold on an AbbVie and Roche clinical trial program for Venclexta/Venclyxto (venetoclax) for the investigational treatmen...
FDA sends a Warning Letter to Nutra Pharma for illegally marketing unapproved products labeled as homeopathic with claims for treating addiction and c...
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.