Brazilian authorities have asked Bayer to recall more than a dozen lots of its Gynera birth control pills.

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.

Takeda Pharma is positioning itself to take over stem cell production in Europe from its partner TiGenix by 2021 after Swissmedic accepted for review the file…

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.

Bristol-Myers Squibb recalled a lot of its anticoagulant Eliquis after discovery of a bottle that contained tablets that were half the prescribed dose.

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.

BioMarin’s Cork, Ireland, bulk biologic manufacturing facility has FDA approval to produce an ingredient of Vimizim used to treat Morquio syndrome.

Regulatory