U.S. FDA Orphan Drug exclusivity provides seven years of market exclusivity for YORVIPATH in the United States for the treatment of hypoparathyroidism in...
Firms Provided Third-Party, Nonclinical Premarket Testing; Agency Review Ongoing U.S. Food and Drug Administration issued warni...
The first and only dual-acting interleukin-23 inhibitor approved in active ulcerative colitis, TREMFYA® showed highly statistically signifi...
- Receipt of RMAT Designation is based on preliminary clinical evidence from the CANaspire Phase 1/2 clinical trial, which showed functional improvements...
Sun Pharma and Israel-based Moebius Medical Limited announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) t...
FDA approves expanded indication making FILSPARI available to patients with IgA nephropathy (IgAN) at risk of progression; updated label includes data sh...
– The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for an updated version of the Novavax COVID-19 Vaccine,...
Novavax expects pre-filled syringes will be broadly available in thousands of locations across the U.S. Novavax's vaccine is the only protein-based op...
Emergent BioSolutions announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (s...
Phase III V-MONO study met its primary endpoints, demonstrating superiority of Leqvio (inclisiran) monotherapy vs both placebo and ezetimibe in LDL-C r...
PI-2620 is in Phase 3 development in Alzheimer’s disease by AC Immune’s partner, LMI This Fast Track designation applies across Al...
BeiGene, a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BGB-16673, an ...
The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is recommended for individuals 6 months of...
Sibel Health announces two additional FDA-clearances enabling its advanced wearable sensors to operate with compatible third party software applications. I...
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