Taiwanese Drugmaker Cited for Lax Testing June 20, 2019 The agency cited the facility’s quality control unit for lacking many written procedures. Read More
Acertara Earns CE Mark for Ultrasound Probe Tester June 19, 2019 The table-top device weighs less than six kilograms. Read More
Catalyst Sues FDA Over $375,000 Rare Disease Treatment June 19, 2019 Catalyst had won orphan status for its version of amifampridine, which it called Firdapse. Read More
FDA OKs Zebra Medical’s AI Triage Software for Intracranial Hemorrhaging June 18, 2019 Intracranial hemorrhages account for about 10 to 20 percent of all strokes. Read More
PTC Therapeutics Wins Expanded Label for Duchenne Muscular Dystrophy June 18, 2019 Emflaza is currently the only drug of its kind for patients two years and older with Duchenne muscular dystrophy. Read More
Delegates Flag Concerns Over EU’s Device, IVD Regulations June 17, 2019 More than 80 percent of IVDs will need to be assessed and certified by a notified body before being placed on the EU market. Read More
ALK Allergy Drug Nothing to Sneeze At, European Regulators Say June 17, 2019 The approval comes after ALK handed up positive results from a Phase 3 trial. Read More
Devicemakers Comment on FDA’s Approach to Machine Learning for SaMD June 14, 2019 GE Healthcare urged the agency to consider an expedited pathway for software changes. Read More
Genentech Wins Accelerated Approval for Chemoimmunotherapy June 14, 2019 The agency previously granted Polivy breakthrough therapy, priority review and orphan drug status. Read More
FDA Urges Sponsors to Loosen Exclusion Criteria to Improve Trial Diversity June 13, 2019 The agency urges sponsors to be as liberal as possible when thinking about exclusion criteria. Read More
FDA Issues Draft Guidance on Vitamin B7 Testing in IVDs June 13, 2019 The agency wants manufacturers of currently marketed devices to consider the recommendations. Read More
FDA OKs EmCyte’s Bone Marrow Aspirate System June 12, 2019 The system is designed for minimally invasive collection. Read More