FDA releases the form FDA-483 with six observations from an inspection at Wichita, KS-based Fagron Compounding Services.
FDA approves Biocon Biologics biosimilars for Amgens Prolia and Xgeva.
FDA issues a draft guidance revising and updating a 2013 guidance on safety labeling changes when new safety information becomes available after a dru...
The House Energy and Commerce Committee unanimously approves legislation to reauthorize FDAs Rare Pediatric Disease Priority Review Voucher program.
FDA publishes a guidance to help sponsors with clinical trials for drugs to treat symptomatic nonerosive gastroesophageal reflux disease in adults.
Johnson & Johnson reports favorable data from the Phase 3 ICONIC-ADVANCE 1 and 2 studies that showed its experimental psoriasis drug icotrokinra outpe...
The Justice Department says Gainesville, FL-based Exactech is paying $8 million to resolve four whistleblowers allegations that the company violated t...
FDA Matters founder Steven Grossman speculates on why FDA commissioner Martin Makary may want to limit or eliminate the role of advisory committees in...
