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.

On the last day of the year, shares of Axsome Therapeutics Inc. rose 22% on news that the U.S. FDA accepted and granted priority review of the company’s supplemental NDA for AXS-05 to treat Alzheimer’s disease agitation, a $1 billion-plus opportunity, scheduling the PDUFA date for April 30.

The U.S. FDA dashed hopes that Corcept Therapeutics Inc. might be able to launch its selective glucocorticoid receptor antagonist in two indications in 2026, issuing a complete response letter for relacorilant for use in patients with hypertension secondary to hypercortisolism, also known as Cushing syndrome. Focus is now on the July 2026 PDUFA date, as Corcept seeks approval for the same drug as a treatment for patients with platinum-resistant ovarian cancer.

The U.S. FDA has approved its first pharma treatment in more than 40 years for motion sickness. The green light for Nereus (tradipitant), from Vanda Pharmaceuticals Inc., was based on three clinical studies, all pivotal, including two phase III real-world trials with patients on boats and another supporting study.

The U.S. FDA recently cleared Medtronic plc’s Hugo robotic-assisted surgery system and CMR Surgical Ltd.’s Versius Plus system, adding new options to the U.S. market to meet rising demand for robotic procedures. While Intuitive Surgical Inc. currently dominates the soft tissue surgical robotics space, these new entrants will provide hospitals and health care systems with greater choices when it comes to purchasing systems and expanding systems.

The U.S. FDA’s final guidance for clinical trial inspections conducted under the bioresearch monitoring (BiMo) program seems to deviate little if at all from the 2024 draft, but that is precisely the rub for some stakeholders. The Advanced Medical Technology Association pressed the agency to ensure that the final guidance takes into account the hazards of electronic access during remote BiMo audits, but the final guidance makes no such concessions.

If the 2025 U.S. life sciences regulatory scene were to be summed up in one word, it would have to be uncertainty. Two words might be more definitive – chaotic uncertainty.