Latest Regulatory Affairs News

Island Pharmaceuticals has raised $350,000 through an options exercise by substantial shareholder MWP Partners, reinforcing confidence in its antiviral drug development pipeline.

Syntara Limited is set to update investors on the clinical progress of its lead drug candidate amsulostat, targeting myelofibrosis, in a webinar scheduled for 11 August 2025. The company highlights recent regulatory milestones and advancing trials.

Syntara Limited has received FDA guidance recommending a Phase 2 controlled trial for its lead drug amsulostat in myelofibrosis, setting the stage for a pivotal Phase 3 study. The company is poised to refine its clinical strategy while advancing a diverse pipeline with key data milestones ahead.

Immutep has received encouraging feedback from the FDA on its immunotherapy eftilagimod alfa combined with KEYTRUDA for patients with low PD-L1 expression in head and neck cancer, opening potential accelerated approval pathways.

Infinity Lithium secures a three-month extension for its San José lithium project amid regulatory challenges, while reshuffling its board to pivot towards Australian precious metals.

PointsBet Holdings has dismissed Betr Entertainment's increased scrip takeover offer, reaffirming its support for MIXI's competing bid amid ongoing regulatory scrutiny.

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.