Moderna submits an EUA for a BA.4/BA.5 Omicron-targeting bivalent booster vaccine that could be available early next month.
Essilor International (Dallas, TX) agrees to pay $16.4 million to resolve allegations that it violated the False Claims Act by paying eye care provide...
Federal Register notice: FDA announces a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting.
Federal Register notice: FDA posts a notification that OMB has approved 11 recent information collections.
CDER plans to review and discuss its proposed Quality Management Maturity program at an 11/2 advisory committee meeting.
FDA issues a safety alert on autoinjector devices that are optional for use with multiple sclerosis therapy glatiramer acetate injection drug products...
FDA issues Pharvaris a clinical hold on two clinical trials of its PHA121, an oral bradykini B2-receptor antagonist for treating and preventing heredi...
FDA releases a revised draft guidance entitled Charging for Investigational Drugs Under an IND: Questions and Answers.
