FDA grants de novo marketing clearance to KCI for Prevena Incision Management System, a negative pressure medical device indicated to aid in reducing ...
FDA grants Farapulse a breakthrough device designation for its Farapulse Pulsed Field Ablation System and its use in treating drug-refractory, recurre...
Bloomberg Law says the Supreme Court is expected to rule in June on a case that could increase the number of False Claims Act cases that are filed.
PhRMA lists seven areas for which it seeks further clarification in an FDA draft guidance on combination product premarket pathway principles.
The International Council for Harmonization releases for public comments a revised draft guideline entitled General Considerations For Clinical Studie...
Bristol-Myers Squibb says its Phase 3 CheckMate-498 trial evaluating Opdivo (nivolumab) versus temozolomide did not meet its primary endpoint of overa...
FDA issues a guidance to help oncology drug sponsors evaluate reproductive toxicity effects of their drugs.
FDA issues a draft guidance to help sponsors and applicants document submission of INDs, NDAs, and BLAs that contain real-world evidence.