Latest Therapeutics News

HeraMED has achieved a significant regulatory milestone with the Therapeutic Goods Administration upgrading its HeraBEAT fetal heart rate monitor to Class IIb, making it the only remote home-use device approved in Australia. This positions the company for a potentially lucrative expansion in the Australian maternity care market.

EVE Health Group has partnered with telehealth provider hubMed to deliver a national patient support program, enhancing care continuity for users of its women’s and men’s health products Dyspro™ and Libbo™.

Dimerix Limited’s ACTION3 Phase 3 trial for DMX-200 in FSGS kidney disease has passed its seventh Independent Data Monitoring Committee review with no safety concerns, reinforcing the drug’s promising safety profile.

Prescient Therapeutics has achieved a key regulatory milestone with the European Medicines Agency granting Orphan Drug Designation for its PTX-100 therapy targeting Cutaneous T-cell Lymphomas, enhancing its commercial and clinical prospects in Europe.

EVE Health Group has partnered with telehealth provider hubMed to deliver a national patient support program, enhancing care continuity for users of its Dyspro and Libbo therapies.

Biotron Limited has launched a $1.5 million non-renounceable rights issue to fund its strategic acquisition of Sedarex Limited and support ongoing drug development programs. The capital raise follows shareholder approval and aims to diversify Biotron’s portfolio with a next-generation general anaesthetic.

Tryptamine Therapeutics has enrolled its second patient in a pioneering clinical trial using IV-infused psilocin to treat Binge Eating Disorder, with first dosing scheduled for December and results expected early next year.

Radiopharm Theranostics has secured ethics approval to begin a Phase 1 clinical trial of RAD 402, a pioneering radiotherapeutic targeting advanced prostate cancer using terbium-161. This marks a significant step in developing a potentially safer, more effective treatment option.

Antaria has disclosed several FDA-identified GMP compliance issues but assures no impact on product quality or supply, committing to expert-led remediation and enhanced training.

Island Pharmaceuticals has secured FDA confirmation that its antiviral Galidesivir can proceed under the Animal Rule pathway for Marburg virus, qualifying for a lucrative Priority Review Voucher. This regulatory milestone accelerates the drug’s path to approval and potential government stockpile inclusion.

Starpharma’s 2025 AGM highlighted breakthrough partnerships and clinical progress, positioning the biotech for growth. Key deals with Genentech and Radiopharm Theranostics underpin a promising pipeline and expanding revenue streams.

Biotron Limited’s lead HBV drug BIT-HBV001 demonstrates superior antiviral activity and synergy with the current standard treatment Tenofovir in preclinical models, advancing hopes for a more effective Hepatitis B therapy.