The FDA’s Oncologic Drugs Advisory Committee cleared the way for a new combination treatment aimed at providing curative therapy for patients with previously untreated large B cell lymphoma.

The Biden administration has asked Congress for $7.2 billion in funding for the FDA for fiscal 2024 — an approximately 10 percent increase over what the agency received in fiscal 2023.

Merck has signed a deal with OPKO Health to develop OPKO subsidiary ModeX’s nanoparticle vaccine candidate targeting Epstein-Barr Virus (EBV). 

Eli Lilly’s antiamyloid antibody solanezumab struck out in a highly anticipated phase 3 preclinical treatment study, failing to alter disease progression in people who had amyloid brain plaques but normal cognition.

A U.S legislator is demanding answers from the FDA over GSK’s alleged “40-year cover-up” of cancer induced by the heartburn drug Zantac (ranitidine).

Covis Pharma is willing to withdraw from the market its premature birth drug Makena (hydroxyprogesterone caproate injection), the company wrote in a letter to the FDA that requests the agency allow it an “orderly wind-down” period rather than an abrupt end to the drug’s availability.

Responding to FDA Commissioner Robert Califf’s recent remarks regarding the value of advisory committee (AdComm) votes, two major industry advocates offered slightly different takes on the question.