Latest Fda News

Island Pharmaceuticals is progressing its broad-spectrum antiviral Galidesivir amid a severe Ebola outbreak, securing government approvals in Uganda and outlining a dual clinical and regulatory development pathway targeting multiple deadly filoviruses.

Alterity Therapeutics has secured official FDA confirmation that a single pivotal Phase 3 trial, backed by prior Phase 2 data, can support approval of ATH434 for Multiple System Atrophy. Trial initiation remains on track for late 2026.

Noxopharm has taken a key regulatory step by requesting a pre-IND meeting with the US FDA for its autoimmune drug candidate SOF-SKN, aiming to smooth the path for clinical development and boost its commercial appeal.

Argent BioPharma has struck a global licensing deal for its CannEpil® epilepsy therapy with Splash Beverage Group, securing US$5.5 million upfront through convertible debt forgiveness and retaining manufacturing and intellectual property rights alongside a 15% royalty on future sales.

Botanix Pharmaceuticals has received an Intention to Grant from the European Patent Office for a patent protecting its Sofdra applicator technology, potentially extending exclusivity in Europe until 2039.

Optiscan Imaging has begun commercial sales of its InSpecta™ microscopic imaging device in the US veterinary sector following FDA clearance, marking its first clinical device launch and a strategic expansion into a $15.87 billion market.

PainChek announces the immediate departure of CEO Philip Daffas, with COO Andy Hoggan stepping in as interim leader amid a strategic pivot to boost US market growth following FDA clearance.

ReNerve Limited has secured regulatory approval to market its flagship NervAlign Nerve Cuff in Indonesia, marking a major step in its Asia-Pacific expansion and unlocking access to one of the region’s largest nerve repair markets.

Starpharma has reached a key milestone in its collaboration with Radiopharm Theranostics, unlocking a $0.5 million option fee and advancing the partnership toward a potential $91 million licensing deal.

Orthocell has secured a strategic foothold in Thailand's $84 million nerve repair sector by appointing MediTime as exclusive Remplir distributor, leveraging established clinical networks to accelerate market penetration.

OncoSil Medical has submitted its Humanitarian Device Exemption application to the FDA for its OncoSil™ device targeting distal cholangiocarcinoma, entering the final review phase with a decision expected within 45 days.

Telix Pharmaceuticals has gained FDA alignment to advance Part 2 of its ProstACT Global Phase 3 trial for TLX591-Tx in metastatic castration-resistant prostate cancer, setting the stage for U.S. enrolment pending regulatory approval.