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Coloplast has signed a $1.3 billion agreement to acquire Kerecis, a biologics wound care manufacturer based in Iceland, with an FDA-cleared patented technology platform based on intact fish skin. Read More
The FDA has classified Draeger Medical’s Oxylog 3000 Plus emergency and transport ventilator as class I, the most serious type of recall because of the risk of serious injury or death. Read More
Multiple U.S. government agencies, in collaboration with India’s Directorate of Revenue intelligence, have stopped over 500 shipments of “illicit, and potentially dangerous, unapproved prescription drugs, combination medical devices, and synthetic drug precursors from reaching American consumers.” Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
Novo Nordisk has sought legal action against 10 medical spas, weight loss and wellness clinics, and compounding pharmacies in four states for illegally selling non-FDA-approved compounded and counterfeit semaglutide products. Read More
The European Medicines Agency (EMA), the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the “extraordinary regulatory flexibilities” that were put in place during the COVID-19 pandemic to ease potential medicine shortages. Read More
The Association of Accessible Medicines (AAM) has filed a lawsuit against a new Minnesota law that controls pharmaceutical pricing, calling the law unconstitutional and discriminatory. Read More
The first wireless pulse-oximetry device for infants has received an FDA 510(k) clearance after first receiving a warning letter for selling the device without the agency’s clearance or approval. Read More
New FDA drug approvals in June include new gene therapies for ambulatory Duchenne Muscular Dystrophy and hemophilia A, a treatment for pediatric growth hormone deficiency and the first ever cell therapy for a severe form of type 1 diabetes. Additionally, the FDA approved a new device for skin repigmentation in patients with vitiligo. Read More
Use of real-world data (RWD) and real world evidence (RWE) continues to gain traction in countries around the world, as seen in a draft reflection paper endorsed by the International Council on Harmonisation and issued for comment by the European Medicines Authority (EMA). Read More