An FDA warning letter has been issued to a CMO that made belladonna-treated teething products that the agency warned may cause seizures in infants.

Just a month after FDA staff gave a ringing endorsement to Pfizer's biosimilar for Amgen's blockbuster Epogen, the agency rejected the drug.

Citing sterility concerns, Hospira, a subsidiary of pharma giant Pfizer, is voluntarily recalling vials used to inject sodium bicarbonate during surgery and in…

The FDA has banned drugs manufactured at three facilities in India operated by Ipca Laboratories as a result of ongoing concerns.

Manufacturing costs are a significant factor in pricing CAR-T cancer meds because of the intensive process required for the personalized treatments.

Women turning to Perrigo’s Option 2 emergency contraceptive may be facing more than one unexpected situation. Some boxes don’t contain the med.

Pfizer's Hospira is recalling one lot of 25% dextrose injection for infants after a customer complained of finding a human hair in a syringe.

Johnson & Johnson is putting behind it the lingering legal problems that stemmed from manufacturing issues that led to recalls some years back.

Drug Safety