Abbreviated new drug application (ANDA) applicants may request a meeting to discuss problems identified in a complete response letter (CRL), according to a final guidance that explains what should be…

A bipartisan bill just introduced in the U.S. House of Representatives seeks to abolish reimbursement restrictions placed on antiamyloid antibodies as a treatment for Alzheimer’s disease. Source: Drug Industry Daily

Despite failing to achieve both its primary and secondary phase 2 endpoints, an investigational oral solution of gold nanocrystals will go forward into open-label extension studies after a subanalysis found…

As part of its commitments under the newly reauthorized Prescription Drug User Fee Act (PDUFA VII), the FDA has launched the Rare Disease Endpoint Advancement (RDEA) pilot that will test…

Now that user fee legislation has passed, the FDA has opened the floodgates on related guidances. Source: Drug Industry Daily

With the Prescription Drug User Fee Act (PDUFA) VII and the other user fee programs now reauthorized, the FDA is announcing work on several new initiatives this week — including…

The U.S. Supreme Court has refused to hear Biogen’s argument that its patent on the blockbuster multiple sclerosis (MS) drug Tecfidera (dimethyl fumarate) should be reinstated as part of the…

Zealand Pharma’s investigational glucagon-like peptide (GLP)-2 analog glepaglutide hit its primary phase 3 endpoint of reducing parenteral nutrition volume in patients with short bowel syndrome, but only when given twice…

Currently idle U.S. generic drug manufacturing capacity could keep the nation’s drug supply chain “secure, robust and resilient,” according to researchers at Washington University’s Olin Business School in St. Louis.…

Just days after Congress reauthorized the third iteration of the biosimilar user fee act, BsUFA III, the FDA has announced that it’s launching a pilot program to improve the efficiency…