We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA is proposing annual dues for sponsors of one or more approved ANDAs to guarantee a more predictable stream of funding that will raise revenues for the agency’s generics program starting in fiscal 2018. Read More
Pfizer says it plans to begin sales of a biosimilar version of Remicade in late November, despite Janssen’s appeal of a ruling that invalidated its patent covering the arthritis therapy. Read More
Akorn Pharmaceuticals continued drug production when equipment malfunctions would normally require it to abort the batch, the FDA said in a Form 483. Read More
The FDA intends to review 90 percent of priority review ANDAs deemed complete within 8 months, according to the agency’s GDUFA II commitment letter. Read More
The FDA awarded clinical trial grants, totaling more than $23 million over four years, for research on 21 rare diseases, including amyotrophic lateral sclerosis, brain tumors, cystic fibrosis and drug-resistant HIV. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use is recommending the approval of five new medicines and three generics to treat a range of illnesses from cancer to HIV. Read More