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Pfizer has released promising results from a global phase 3 trial of its non-small cell lung cancer (NSCLC) investigational treatment, Lorbrena (lorlatinib). Read More
The FDA will analyze initial promotional materials from drug companies within five business days of receiving them to see if they qualify for priority “core launch” review, said Susannah O’Donnell, leader of the review team in the agency’s Office of Prescription Drug Promotion (OPDP) in a Friday update on the program. Read More
The FDA has granted an Emergency Use Authorization (EUA) for Eli Lilly’s rheumatoid arthritis drug Olumiant (baricitinib) in combination with Gilead Sciences’ antiviral Veklury (remdesivir) for treatment of COVID-19 patients needing supplemental oxygen. Read More
The World Health Organization (WHO) released revised guidance on Gilead Sciences’ antiviral Veklury (remdesivir) after an expert panel review of multiple trials found no evidence for the drug’s effectiveness in treating COVID-19. Read More
The Trump administration on Friday rolled out a pair of final rules meant to reduce high U.S. drug prices, including the “most favored nations” strategy strongly opposed by the pharma industry, possibly marking the president’s last significant actions on drug pricing. Read More
As the countdown begins toward an eagerly anticipated FDA authorization for Pfizer’s COVID-19 vaccine candidate, an advisory committee of the Centers for Disease Control and Prevention (CDC) is meeting today to discuss the phased distribution of coronavirus vaccines. Read More
The FDA has granted a priority review to Sanofi’s biologics license application (BLA) for an experimental enzyme replacement therapy for patients suffering from Pompe disease, a rare illness that causes muscle deterioration and reduced lung capacity. Read More
Better communications between the FDA and sponsors, and more clarity from the agency on the issue of interchangeability, were among the suggestions from industry yesterday at a public meeting on the next iteration of the user fee program under the Biosimilar User Fee Act of 2017, dubbed BSUFA III. Read More