Browsing Tag
FDA
316 posts
Moderna faces fresh mRNA patent assault from CureVac as BioNTech tightens legal grip on COVID-19 vaccine royalties
Moderna just settled $950 million in mRNA litigation. Now BioNTech-owned CureVac wants Spikevax royalties too. The patent war is widening.
hVIVO (AIM: HVO) wins world-first Phase III whooping cough challenge trial contract with ILiAD Biotechnologies
hVIVO (AIM: HVO) signs its largest human challenge trial contract with ILiAD Biotechnologies for a world-first pivotal Phase III pertussis vaccine study. Read what it means for investors.
Nuvalent (NUVL) brings full ALKOVE-1 dataset to ASCO 2026 oral session weeks after neladalkib FDA filing
Nuvalent (NUVL) brings pivotal ALKOVE-1 neladalkib data to ASCO 2026. Here's what the oral session means for its dual NDA strategy and ALK lung cancer treatment.
Why eftilagimod alfa’s soft tissue sarcoma data now matters more than ever for Immutep Limited
Immutep Limited’s soft tissue sarcoma data may now define eftilagimod alfa’s future. Find out why this could reshape its oncology strategy.
How GTx-104 may improve ICU dosing consistency in subarachnoid hemorrhage
How Grace Therapeutics’ GTx-104 could improve ICU dosing consistency and reshape hospital economics in subarachnoid hemorrhage care. Read the full BNT analysis.
Could essential tremor finally be entering a new treatment era after Praxis’ Phase 3 results?
Praxis Precision Medicines’ Phase 3 results could reshape essential tremor treatment and re-rate the neurology market. Read what this means for investors.
Immutep (ASX: IMM) surges 48% on FDA orphan drug designation: Is the STS pivot the new thesis?
Immutep (ASX: IMM) jumped 48% after the FDA granted orphan drug status for eftilagimod alfa in soft tissue sarcoma. Here is what the EFTISARC-NEO data means for the investment case.
Prader-Willi syndrome: What families need to know about causes, care, and the treatment breakthrough that just changed everything
Prader-Willi syndrome explained for families and carers: causes, diagnosis, care, the 2025 FDA approval of Vykat XR, and what the latest trials mean for treatment.
Viatris and the presbyopia drug race: What ASCRS 2026 data means for the MR-141 FDA decision in October
Viatris presents full VEGA-3 Phase 3 data for MR-141 presbyopia drop at ASCRS 2026. FDA PDUFA date is October 17, 2026. Market context, competitive landscape, and investor outlook.
Could MTX-001 emerge as a late-stage wound care contender after the latest FDA alignment?
Could MTX-001 emerge as a late-stage wound care contender? Read why Merakris Therapeutics’ latest FDA alignment may reshape the commercial outlook.