The House Energy and Commerce Committee unanimously approves legislation to reauthorize FDAs Rare Pediatric Disease Priority Review Voucher program.
FDA approves an AstraZeneca supplemental NDA for Airsupra (albuterol/budesonide) to expand the drugs labeling to reflect a 46% reduction of severe exa...
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...
AstraZeneca reports that data from a Phase 3 trial of Fasenra (benralizumab) did not achieve the primary endpoint in patients with chronic obstructive...
FDA publishes a draft guidance to help sponsors with clinical trials for drugs to treat disseminated coccidiomycosis.
