New Jersey-based CDMO Catalent signed a deal with US WorldMeds to manufacture lofexidine, an investigational drug used to treat opioid withdrawal.
The FDA is reorganizing its manufacturing inspections, saying the new system should speed drug approvals and reduce surprises for drugmakers.
Mylan and Biocon, whose Herceptin biosimilar was to be considered by the FDA Sept. 3, has had its target date delayed three months.
After issuing a warning letter to India’s Mahendra Chemicals, the agency has followed up by putting its API operation after finding a data and document…
The FDA has taken a close look at Hetero Labs' finished products plant in Telangana, India, and decided it didn't like what it found.
A generics maker in the U.K. had its manufacturing certification pulled after regulators found data-reporting issues.
Approval of Acorda's candidate for an inhaled drug for Parkinson's disease is in jeopardy because of FDA questions about Acorda's manufacturing.
The worst is over for a CordenPharma sterile manufacturing plant in Italy that was slapped last year with an FDA warning letter.
The FDA has classified the ongoing recall by drug wholesaler Truxton of 18 lots of phenobarbital and amitriptyline tablets as Class I and Class II recalls.…
Valeant says the situation is looking up at that Bausch + Lomb plant that has twice been responsible for Valeant receiving a CRL for a new eye drug.