Latest Pharmaceuticals News

Mayne Pharma has addressed a sharp share price decline following the public release of an FDA Untitled Letter, confirming no undisclosed material information and reaffirming compliance with ASX rules.

Neuren Pharmaceuticals has received official FDA minutes confirming the primary endpoints for its pivotal Phase 3 trial of NNZ-2591 targeting Phelan-McDermid syndrome, reinforcing the positive signals from earlier studies.

Botanix Pharmaceuticals has clarified that recent share price movements are linked to a rumored US executive order on drug pricing, confirming no undisclosed material information. The company reassures investors of compliance with ASX disclosure rules amid market speculation.

Botanix Pharmaceuticals clarifies its lead product Sofdra is unlikely to face price cuts under the proposed US executive order on drug pricing, citing its exclusive US market approval and distinct formulations abroad.

Mayne Pharma Group has acknowledged a delayed filing of a director's interest notice due to administrative oversight and is taking steps to reinforce compliance with ASX disclosure rules.

Acrux Limited, partnering with TruPharma, has introduced its Dapsone 7.5% Gel in the US, featuring a unique tube packaging that aims to improve patient convenience and reduce environmental impact.

Neuren Pharmaceuticals reports a robust 11% rise in DAYBUE™ US net sales for Q1 2025, alongside a 17% jump in royalty income, setting the stage for an anticipated European market entry in early 2026.

Algorae Pharmaceuticals has partnered with Peter MacCallum Cancer Centre to validate AI-predicted drug combinations across multiple cancer types, aiming to accelerate its oncology pipeline development.

Nyrada’s experimental drug NYR-BI03 shows promising cardioprotective and anti-arrhythmic effects in animal models, reinforcing its potential as a treatment for acute myocardial infarction.

Mayne Pharma has announced the expiration of the US antitrust waiting period, a critical step forward in Cosette Pharmaceuticals' proposed acquisition. The transaction now moves closer to completion, pending other regulatory and shareholder approvals.

Echo IQ has raised $17.3 million through a strongly supported institutional placement to fund US commercialization and FDA approval efforts for its EchoSolv AI cardiology products.

Althea Group Holdings has agreed to sell its pharmaceutical assets to Tasmanian Botanics, enabling a strategic pivot towards the booming North American THC-infused beverage market.