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LivaNova says its aura6000 obstructive sleep apnea treatment met the safety and efficacy endpoints in the OSPREY trial in adults.[ Price : $8.95]
GAO healthcare director Mary Denigan-Macauley says FDA needs a plan and a strategy for recruiting and retaining new facility inspe...[ Price : $8.95]
FDA clears a GE HealthCare 510(k) for its Signa Magnus, a 3.0T high-performance, head-only MRI scanner.[ Price : $8.95]
Adaptimmune Therapeutics plans a rolling BLA submission for cell therapy lete-cel in certain people with synovial sarcoma or myxoi...[ Price : $8.95]
FDA releases the form FDA-483 with seven observations from an inspection at the U.S. Specialty Formulations outsourcing facility i...[ Price : $8.95]
FDA publishes a draft guidance on the nonclinical safety assessment of oligonucleotide-based therapeutics.[ Price : $8.95]
FDA clears a NovaBone Products 510(k) for its NovaBone Putty and its expanded use in the intervertebral disc space.[ Price : $8.95]
Six Squire Patton Boggs attorneys lay out the impact of four recent Supreme Court decisions on several aspects of FDA regulation.