Latest Regulatory Affairs News

Prescient Therapeutics reported an 11.1% reduction in net loss for FY2025, progressing its lead candidate PTX-100 into Phase 2a trials with FDA Fast Track and Orphan Drug designations, supported by a recent $9.8 million capital raise.

LTR Pharma’s intranasal ED treatment SPONTAN achieves peak effect up to five times faster than oral tablets, according to new peer-reviewed clinical data published in a leading European journal.

Neurizon Therapeutics faces a delay in FDA review for its lead ALS therapy NUZ-001, with a new decision expected by early October amid agency-wide staffing challenges.

Argenica Therapeutics has received detailed FDA feedback outlining specific data requirements to lift the clinical hold on its ARG-007 stroke trial in the US, setting a clear path forward for its neuroprotective drug.

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.