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In a pivotal move to enhance public health, the U.S. Food and Drug Administration (FDA) has released draft guidance for Phase II of its voluntary ...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
Vertex Pharmaceuticals’ suzetrigine approved for FDA review: A breakthrough in pain management
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) has announced a pivotal advancement in the treatment of acute pain. The U.S. Food and Drug Administration (FDA) has officially ... Read More
Setback for diabetes innovation: FDA puts brakes on Novo Nordisk’s once-weekly insulin icodec
Novo Nordisk announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics License Application for its ... Read More
Genentech announces reintroduction of Susvimo for Wet AMD treatment in US
Genentech, a key member of the Roche Group, has officially announced the reintroduction of Susvimo (ranibizumab injection) 100 mg/mL, a cutting-edge treatment for wet, or ... Read More
Swedish Match aims to renew and expand modified risk tobacco product status in US
Swedish Match USA, Inc., part of the Philip Morris International Inc. (NYSE: PM) family, made a significant presentation on June 26, 2024, to the Tobacco ... Read More