Latest Fda News

Artrya is advancing its commercial footprint in the US with two health systems now generating revenue and FDA clearance for its Salix Coronary Flow module expected in H2 2026.

Cyclopharm’s Technegas® has been named the preferred ventilation agent in new US lung imaging guidelines, marking the first update in 14 years and potentially accelerating adoption across American hospitals.

Saluda Medical capped FY26 with a 28% revenue surge, beating guidance at US$90.2 million, while FDA approval for its CAP24 paddle lead opens a new US surgical market segment.

Amplia Therapeutics reported encouraging mature data from its ACCENT trial, initiated a Phase 2b pancreatic cancer study, launched an ovarian cancer trial, and refreshed its board leadership while maintaining a solid cash balance of A$24 million.

Vitrafy Life Sciences reported a breakthrough 94.4% post-thaw platelet recovery in US Army Phase II testing, secured major US blood network partnerships, and raised $32 million to accelerate US expansion and device manufacturing.

NeuroScientific Biopharmaceuticals achieved an 80% clinical response rate in fistulising Crohn’s disease patients treated under the TGA Special Access Scheme, advancing plans for Phase 2 trials and manufacturing scale-up.

LTR Pharma’s SPONTAN shows rapid absorption in Phase II interim data while securing key US commercial deals for ROXUS, setting the stage for a US market entry later this year.

Clinuvel Pharmaceuticals targets year-end for topline results from its pivotal vitiligo trial of SCENESSE® combined with narrowband UVB, aiming to expand the drug's use beyond its current rare disease indication.

dorsaVi has unveiled Sensor v6.5, its first wearable sensor that processes and acts on movement data in real time without cloud reliance, marking a key milestone in wearable Physical AI technology.

ImpediMed reported a 3% revenue increase to $3.6 million in Q4 FY26, bolstered by a $15.3 million capital raise and strategic leadership hires as it pushes growth in cancer survivorship, heart health, and weight management.

Argent BioPharma has eliminated US$5.5 million in secured debt through a global licensing agreement for its CannEpil® epilepsy therapy, while completing a key acquisition and advancing clinical trials in veterinary therapeutics.

Lumos Diagnostics reported a 6% revenue increase to US$13.2 million for FY26, driven by an 875% surge in FebriDx® sales following a pivotal CLIA waiver. The company expanded U.S. adoption to 170+ healthcare sites and secured milestone payments exceeding US$6 million.