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FDA expands IONS' Tryngolza label to treat severe hypertriglyceridemia
Ionis Pharmaceuticals IONS announced that the FDA has approved its wholly owned drug, Tryngolza (olezarsen), for a new ...
Gore & Associates announced that the FDA approved updated labeling for the Gore Excluder abdominal aortic aneurysm (AAA) ...
On Friday, the U.S. Food and Drug Administration (FDA) approved Pfizer Inc.’s PFE and Astellas Pharma Inc.’s ALPMF ALPMY ...
FDA clearance establishes the first CDK4/6 inhibitor indication spanning HR+ metastatic disease regardless of HER2 status, creating a new maintenance strategy for HR+/HER2+ tumors. PATINA randomized ...
The FDA has approved a subcutaneous version of isatuximab (Sarclisa Escena, Sanofi-Aventis) for several multiple myeloma (MM) ...
The FDA has approved an updated label for beremagene geperpavec-svdt (B-VEC), a topical gene therapy for dystrophic epidermolysis bullosa (DEB), which expands the indication from ages 6 months and ...
PITTSBURGH, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced today that the United States Food and Drug Administration (FDA) approved a label update ...
The Hikma Court correctly held that a generic manufacturer should not be liable for induced patent infringement if it carves ...
A new guidance document published by the US Food and Drug Administration (FDA) is intended to clarify how drugs approved through the accelerated approval pathway should be labeled. FDA's accelerated ...
The US Food and Drug Administration (FDA) on Tuesday finalized guidance on labeling drugs and biologics approved under the accelerated approval pathway. FDA's accelerated approval program allows the ...
Incyte INCY announced that the FDA has approved the label expansion of Opzelura (ruxolitinib) cream 1.5%. Opzelura, a topical Janus kinase (JAK) inhibitor, is now approved for the short-term and ...
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