China’s National Medical Products Administration (NMPA) has issued guidance governing online sales of medical devices with a focus on inspections of the products’ manufacturing facilities. The agency made it clear that the manufacturer will have to deal promptly with any deviations from the regulations or face enforcement action, signaling a new era of tighter scrutiny of online sales of these products.
With the stroke of a pen and no input from the CDC’s Advisory Committee for Immunization Practices, acting CDC Director Jim O’Neill cut the number of vaccines the agency routinely recommends for children to 11 on Jan. 5, down from 17 in 2024.
After welcoming the political agreement on the EU pharmaceutical legislation in December 2025, the EMA says it will be devoting 2026 to “intense preparation” for its implementation.
With plans in place to launch global pivotal testing of GH-001, its inhaled version of psychedelic mebufotenin (5-MeO-DMT), in treatment-resistant depression in 2026, GH Research plc reported the lifting of a U.S. FDA clinical hold, enabling U.S. subject enrollment. The firm now will seek a meeting with the agency to discuss trial design.
The U.K. National Institute for Health and Care Excellence posted a draft update on its recommendations for ovarian cancer testing, proposing several changes that may lead to earlier intervention in the ovarian cancer disease cycle.
Australia’s Therapeutic Goods Administration posted a proposed rework of the agency’s conformity assessment procedures that would align with EU regulations, but the agency stated clearly that it is aware of some of the hazards of further alignment with the troubled European regulations.
Fibrobiologics Inc. has filed an IND application with the FDA seeking to begin first-in-human trials of CYPS-317, an investigational allogeneic fibroblast spheroid-based therapy for the treatment of moderate to severe psoriasis.
Receiving a third complete response letter (CRL) from the U.S. FDA for its bevacizumab formulation, ONS-5010, to treat wet age-related macular degeneration, Outlook Therapeutics Inc. watched its stock (NASDAQ:OTLK) plummet nearly 62% to a 52-week low of 60 cents on Jan. 2.
In 2025, the momentum behind robotic-assisted surgical systems continued to accelerate on the back of increasing demand for minimally invasive procedures. In many parts of the world, these technologies are reshaping surgical procedures by improving precision and efficiency through high resolution imaging, AI and refined instrument control. This is resulting in fewer complications, faster recovery and improved patient outcomes.
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