Browsing Tag
FDA
341 posts
Johnson & Johnson’s RYBREVANT approved by FDA as second-line option for EGFR-mutated NSCL
The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson’s RYBREVANT (amivantamab-vmjw) in combination with chemotherapy…
September 20, 2024
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…
September 19, 2024
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…
September 18, 2024
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…
September 14, 2024
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…
August 25, 2024
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…
August 18, 2024
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…
August 18, 2024
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.…
August 16, 2024
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…
August 12, 2024
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)…
August 3, 2024