The U.S. Food and Drug Administration decided to put together an advisory committee meeting of outside experts to review a New Drug Application (NDA) for FibroGen and partner AstraZeneca’s investigational anemia therapy roxadustat.
The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices voted to recommend the use of Moderna Inc.’s Covid-19 vaccine on people 18 years of age and older.
U.S. coronavirus deaths soared to a daily record of 3,580 and hospitalizations rose for the 19th straight day on Dec. 16, ramping up the stakes as regulators on Dec. 17 considered whether to approve a second Covid-19 vaccine.
Novartis’ bid to pump up sales of Entresto beyond $5 billion annually got a boost when a U.S. Food and Drug advisory panel recommended the heart failure medicine be used to treat a different form of the disease.
The U.S. government will get an additional 100 million doses of Moderna Inc.’s Covid-19 vaccine candidate, expected to be delivered in the second quarter of 2021 if authorized.
A panel of outside advisers to the U.S. Food and Drug Administration is meeting on Dec. 10 to weigh whether to recommend that the regulatory agency authorize Pfizer’s coronavirus vaccine for emergency use, one of the last steps before vaccinations could begin.
Former U.S. Presidents Barack Obama, George W. Bush and Bill Clinton said they were willing to be vaccinated against the novel coronavirus on television in order to ease any public skepticism over the safety of new vaccines.
Biogen Inc.’s shares slumped as the drugmaker’s chances of getting a regulatory approval for the experimental Alzheimer’s treatment aducanumab suffered a blow after a panel of experts to the U.S. Food and Drug Administration voted against the medicine.
A panel of outside advisers to the U.S. Food and Drug Administration voted that one of two large studies on Biogen Inc.’s experimental Alzheimer’s disease drug cannot be viewed alone without regard for the other failed trial.
Shares of Alkermes were up in trading after the Ireland-based company announced the experimental schizophrenia drug ALKS 3831 was overwhelmingly supported by an advisory committee for the U.S. Food and Drug Administration.