Latest Pharmaceuticals News

PYC Therapeutics has gained Orphan Drug Designation from the European Medicines Agency for its VP-001 candidate targeting Retinitis Pigmentosa type 11, enhancing its regulatory and commercial pathway in Europe.

Island Pharmaceuticals has cleared a major regulatory hurdle with the US FDA, confirming a clinical development path for its antiviral Galidesivir under the Animal Rule. Backed by a $9 million capital raise and strategic partnerships, the company is poised for potential US government procurement and biodefence market entry.

The FDA has removed the postmarketing cardiac repolarization study requirement for Clinuvel's SCENESSE®, reflecting confidence in its long-term safety profile. This marks a regulatory milestone for the only approved treatment for erythropoietic protoporphyria in the US.

Neuren Pharmaceuticals reported a solid A$30.4 million net profit in 2025, powered by a 15% rise in DAYBUE® royalties. The company is progressing its NNZ-2591 Phase 3 trial for Phelan-McDermid syndrome and has initiated a share buy-back amid perceived undervaluation.

CLINUVEL Pharmaceuticals has received final scientific advice from the European Medicines Agency on the design of its pivotal Phase III trial for SCENESSE in vitiligo, endorsing a comprehensive evidence approach and prioritising patients with darker skin tones.

Racura Oncology has detailed how its lead drug candidate, (E,E)-bisantrene, silences the cancer-driving MYC gene by stabilising G-quadruplex DNA structures, providing critical preclinical validation ahead of ongoing clinical trials.

BPH Global has secured a key coastal site in South Sulawesi to boost its seaweed cultivation and processing capabilities, underpinning its vertical integration strategy across food and bio stimulant markets.

Noxopharm reports preclinical data revealing SOF-SKN’s active ingredient remains in skin tissues for about 3.5 days with minimal systemic absorption, supporting less frequent dosing and sustained activity for cutaneous lupus treatment.

Firebrick Pharma secured regulatory approval for Nasodine Nasal Spray in Indonesia and launched Nasodine Throat Spray in Singapore and Fiji, while raising $1.5 million to fuel growth. The company aims to quadruple its product and market footprint within three years.

Recce Pharmaceuticals has cleared a critical regulatory hurdle in Indonesia with a successful inspection of its Phase 3 clinical trial site for diabetic foot infections, paving the way for potential approval in 2026 amid a large and growing market.

Bioxyne Limited posted a record $21.3 million revenue in Q3 FY26, driven by strong demand for medicinal cannabis and psychedelics. The company secured a manufacturing agreement with Aurora Cannabis and initial orders for GMP psilocybin capsules, reaffirming FY26 guidance.

4DMedical lands a contract with pharma giant GSK, gains UKCA certification for its CT:VQ™ lung imaging technology, and joins the S&P/ASX 200, marking a significant step in its global expansion.