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...
Moderna, Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion r...
Orphan designation shows recognition of therapeutic potential of drug candidate SBL01 targeting two regulated cell death pathways European Medicines A...
– The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for an updated version of the Novavax COVID-19 Vaccine,...
Singaporean government has introduced a subsidy program to make cell, tissue, and gene therapy products (CTGTP) more accessible to patients. Begi...
Guardant Health Japan Corp. (HQ: Minato-ku, Tokyo/ Representative Director: Mika Takaki), a leading precision oncology company, announced that the M...
Nucala is the first and only biologic in Japan with a four-weekly dosing schedule for this condition Chronic rhinosinusitis with nasal polyps (CRSwNP)...
Phase III V-MONO study met its primary endpoints, demonstrating superiority of Leqvio (inclisiran) monotherapy vs both placebo and ezetimibe in LDL-C r...
Distributed through LillyDirect®'s self-pay channel, Zepbound single-dose vials are at least 50% less than the list price of all other incr...
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