Latest Regulatory Affairs News

Cambium Bio has cleared key regulatory hurdles for its lead dry eye disease treatment, Elate Ocular, and strengthened its balance sheet with a $2.12 million placement to support upcoming Phase 3 trials.

Neurotech International reports encouraging Phase I human pharmacokinetic results for its pediatric cannabinoid drug NTI164, alongside published clinical trial data in Rett Syndrome and key regulatory progress in the US and Australia.

Titanium Sands Limited has secured retention licenses for four critical exploration areas and is progressing its Environmental Impact Assessment in Sri Lanka, while engaging government officials and local landowners to navigate regulatory hurdles.

Dome Gold Mines reports delays in its Sigatoka desilting project due to local activist opposition, while progressing its feasibility study and securing key license renewals in Fiji.

Alterity Therapeutics has secured U.S. FDA Fast Track designation for its drug ATH434 targeting Multiple System Atrophy, supported by promising Phase 2 clinical trial data showing slowed disease progression and a solid safety profile.

Syntara Limited reports encouraging Phase 2 data for its lead drug amsulostat in myelofibrosis, secures FDA Fast Track status, and expands clinical programs into myelodysplastic syndrome and keloid scars.

Kingsrose Mining advances its Finnmark exploration with promising new magnetic and conductive anomalies, while BHP withdraws from Central Finland to concentrate resources. Leadership changes and a robust cash position set the stage for an active year ahead.

Neurizon Therapeutics has made significant strides in developing its lead ALS drug candidate NUZ-001, unveiling a new liquid formulation and submitting a key regulatory response to the FDA. Clinical and preclinical data bolster hopes for broader neurodegenerative applications.

Predictive Discovery has released a Definitive Feasibility Study for its Bankan Gold Project, confirming a robust 12.2-year mine life with strong financial returns and advancing key permits toward production.

LTR Pharma has initiated commercial distribution of its nasal spray SPONTAN through Australia's Symbion pharmacy network and is advancing ROXUS development for a US launch in early 2026, while expanding its pipeline with a new intranasal treatment for swallowing disorders.

BPH Energy’s June quarter update highlights ongoing legal proceedings over the PEP-11 permit, promising progress in AI-driven brain monitoring technology, and strategic moves toward hydrogen production facilities, supported by a robust cash reserve.

Neurizon Therapeutics has formally responded to the FDA's clinical hold on its lead ALS drug NUZ-001, submitting new animal safety data. The company aims to join the HEALEY ALS Platform Trial by late 2025, pending regulatory approval.