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.
Lucid Pharma issued a nationwide voluntary recall of about 69,000 extended-release capsules of venlafaxine hydrochloride, which is used as an antidepressant.
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.
The European Union this week posted regulations that upon the U.K.’s exit for the EU its API makers will be treated like those from China and India.
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.