The cancer drugmaker pled guilty of violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to investigators in federal court.
Spectrum Pharmaceuticals announced that an inspection of the Hanmi Bioplant in South Korea will be necessary before the U.S. Food and Drug Administration can approve the company’s Biologics License Application for Rolontis (eflapegrastim).
Eli Lilly hired an independent consultant to review a plant producing the company’s Covid-19 antibody drug after receiving a notice from the U.S. health regulator.
Novavax Inc. expects filing for approval of the company’s Covid-19 vaccine candidate in the United States in December, Chief Executive Stanley Erck said in an interview for Czech daily Hospodarske Noviny.
China’s SinoVac is starting Phase III trials of a potential coronavirus vaccine, becoming one of three companies to move into the late stages in the race to develop an inoculation against the disease.
