Longboard Pharmaceuticals shares see spike as FDA recognizes potential of bexicaserin in Dravet syndrome
Shares of Longboard Pharmaceuticals, Inc. surged on Thursday after the United States Food and Drug Administration (FDA) granted both Rare Pediatric Disease designation and Orphan ... Read More
Theratechnologies faces critical disruption in EGRIFTA SV supply following FDA-induced factory shutdown
Theratechnologies Inc., a leading biopharmaceutical company based in Montreal, has announced a potentially significant disruption in the supply of its body fat reduction medication, EGRIFTA ... Read More
New hope for eczema sufferers as FDA approves Eli Lilly’s EBGLYSS
Eli Lilly and Company (Lilly) has secured approval from the U.S. Food and Drug Administration (FDA) for its new biologic treatment, EBGLYSS (lebrikizumab-lbkz), for moderate-to-severe ... Read More
GSK secures FDA breakthrough therapy designation for GSK5764227 in lung cancer treatment
GSK plc (LSE/NYSE: GSK) has announced a significant milestone in its oncology program, with the US Food and Drug Administration (FDA) granting Breakthrough Therapy Designation ... Read More
Phanes Therapeutics’ PT217 receives FDA orphan drug designation for neuroendocrine carcinoma
Phanes Therapeutics, Inc., a clinical-stage biotechnology company dedicated to advancing oncology treatments, has achieved a significant milestone with the granting of Orphan Drug Designation (ODD) ... Read More
FDA sets bold new sodium reduction targets—what this means for your food and health!
In a pivotal move to enhance public health, the U.S. Food and Drug Administration (FDA) has released draft guidance for Phase II of its voluntary ... Read More
Say goodbye to clinic visits: NOWDiagnostics’ FDA-approved syphilis test is here!
NOWDiagnostics, Inc. (NOWDx) has made a groundbreaking advance in diagnostic testing with the recent approval from the U.S. Food and Drug Administration (FDA) for its ... Read More
Ascendis Pharma bags YORVIPATH FDA approval for adult hypoparathyroidism
In a landmark decision, the U.S. Food and Drug Administration (FDA) has granted approval to Ascendis Pharma A/S’s YORVIPATH (palopegteriparatide), making it the first and ... Read More
GSK secures expanded approval for Jemperli from FDA: A major advancement in endometrial cancer treatment
In a landmark decision, the US Food and Drug Administration (FDA) has extended its approval of Jemperli (dostarlimab) to include all adult patients with primary ... Read More
FDA committee endorses Zevra Therapeutics’ arimoclomol as a treatment for Niemann-Pick Disease Type C
In a notable advancement for rare disease treatment, Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) has received a significant endorsement from the U.S. Food and Drug Administration ... Read More