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More than a year after being warned by the FDA for poor quality, Alexion Pharmaceuticals received a fresh Form 483 for problems surrounding gowning procedures and other quality issues. Read More
The FDA has cited two compounding pharmacies for making unapproved and contaminated drugs, and for poor sterile processing practices, the latest indication that the agency won’t let up on larger facilities. Read More
Iroko Pharmaceuticals’ low-dose painkiller Zorvolex is now available for patients with osteoarthritis pain, following FDA’s approval for the second indication. Read More
The FDA has warned four generic drug manufacturing facilities that they haven’t paid their GDUFA fees for the last two fiscal years, meaning all of their products are automatically misbranded. Read More
The FDA has shed light on how amendments to an NDA, BLA or supplement may affect review timelines established under the 2012 prescription drug user fee program. Read More
Actavis has launched a generic challenge against UCB’s Parkinson’s disease drug Neupro, and is facing a patent infringement lawsuit as a result. Read More
Argentina recently agreed to open its borders to finished drug products from India, a policy change applauded by Indian manufacturers who now have access to the multi-billion-dollar market. Read More
Generic versions of Ferring Pharmaceutical’s menstrual bleeding drug Lysteda can move forward after the brandmaker lost a pair of appeals in patent infringement lawsuits seeking to block ANDAs against the product. Read More
Drugmaker ViiV Healthcare is set to launch its triple combination HIV therapy Triumeq in the U.S., after receiving a green light from the FDA. Read More
Swiss pharmaceutical company Roche said yesterday it will acquire California-based biotechnology firm InterMune for $8.3 billion, in a deal that allows Roche to strengthen its respiratory therapy portfolio. Read More