FDA sends Warning Letters to Cao Medical Equipment Co., Gentech and Hybrid Pharma.
FDA approves a Slayback Pharma ANDA for a generic form of Amags Makena.
FDA releases an FDA-483 with 11 observations from an inspection at the Intact Pharmaceuticals outsourcing facility.
Adamis Pharmaceuticals files a 505(b)(2) NDA for its naloxone pre-filled single dose syringe product candidate, indicated for treating opioid overdose...
FDA approves Alexions Ultomiris to treat paroxysmal hemoglobinuria in adult patients.
FDA says Torrent has recalled two lots of losartan potassium 100 mg tablets due to the presence of NDEA.
FDA warns Genetech about many violations involving its processing of human umbilical cord blood derived cellular products distributed to Liveyon LLC f...
FDA partially grants an Allergan petition seeking added bioequivalence assurances for irritable bowel syndrome drug Linzess (linaclotide).