Latest Fda News

Avecho Biotechnology has secured a unanimous recommendation to continue its Phase III insomnia trial without increasing sample size, alongside raising $1.9 million through option exercises and bolstering its cash position to $6.6 million.

Cleo Diagnostics has entered the critical Analytical Validation phase for its ovarian cancer blood test, progressing toward an FDA 510(k) submission targeted for the first half of 2027. The company also secured a U.S. reimbursement pathway to support early market entry post-clearance, backed by a cash balance of A$6.2 million.

ReNerve Limited delivered its strongest sales quarter ever with $211,000 in revenue, boosted by new distribution deals in Asia-Pacific and a $5 million funding facility to underpin growth.

AdAlta has completed a key US$1 million milestone payment securing rights to its lead CAR-T therapy EW-001 outside Greater China, progressed Australian manufacturing with first runs expected late 2026, and is preparing for a critical pre-IND meeting with the US FDA.

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.