Browsing Tag
FDA
341 posts
Mirum Pharmaceuticals (NASDAQ: MIRM) jumps 13% after VISTAS Phase 2b PSC win
Two Phase 2b wins in seven days. A pre-NDA meeting this summer. Mirum is starting to look less like a single-product rare disease story.
Is setmelanotide the first true disease-targeted therapy for hypothalamic obesity?
Is setmelanotide redefining hypothalamic obesity treatment? Explore what Rhythm Pharmaceuticals, Inc.’s EU approval means for markets and growth.
Can the BACKBEAT trial validate a new category of device-driven hypertension therapy?
What does the BACKBEAT trial mean for Medtronic plc and Orchestra BioMed Holdings, Inc.? Discover the future of device-driven hypertension therapy.
Cataract surgery’s hidden battleground: How OVDs became strategic for Alcon, BLCO and JNJ
Cataract surgery is exploding globally. The gel that keeps the eye open during it has become a strategic battleground for Alcon, BLCO and JNJ.
GSK trades near 2,027p as Q1 core EPS rises 9%, full-year 2026 guidance reaffirmed
GSK beat the top line and held guidance, but the harder question is whether Specialty Medicines can keep outrunning the Vaccines and General Medicines drag.
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.