Inflammatix, a pioneering host response diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing... Jan 17, 2025, 18:00 ETMediBeacon® Transdermal GFR System Receives FDA Approval to Assess Kidney Function ...
Supreme Court, where justices heard arguments on a case involving the FDA's approval and regulations for the use of mifepristone. Mar 26, 2024 01:56 U.S. Supreme Court to hear arguments on abortion pill mifepristone This week, abortion access returns to the U.S. Supreme Court, nearly...
BiotechJonathan WosenandMatthew Herper STAT Plus:Ionis blazed trails in genetic medicine. On the cusp of a major approval, can it also be a commercial success? Next Page » Sign up for our morning rounds newsletter
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Presents articles pertaining to the approvals made by the United States Food and Drug Administration (FDA) on ophthalmic drugs. Application approved by the FDA from KeraVision Inc. to finish enrolling patients in the Intacs clinical trials for myopia treatment; Completion of the clinical trials of...
"Today's approval represents the first FDA-approved non-opioid treatment for the management of opioid withdrawal symptoms and provides a new option that allows providers to work with patients to select the treatment best suited to an individual's needs," said Sharon Hertz, director of the Divisio...
FDA decisions (approvals/complete response letter/delay) According to special statuses for treatment options, including orphan drug designation, rare disease designation, accelerated approval, priority review etc. FDA’s Advisory Committee, or Adcom, meetings Review meetings with FDA (pre-investigational ...
News of the potential approval comes as the FDA is demandingmore researchinto many sunscreeningredientscurrently on the U.S. market, over safetyquestions. The FDA has also been facingcriticismfrom members of Congress, frustrated with the gulf between the U.S. market versus thenewer sunscreen optio...
News The FDA has approved a new use for AstraZeneca’s Farxiga (dapagliflozin) to reduce risk of cardiovascular death and hospitalisation with heart failure, in adults with reduced ejection fraction heart failure, with or without type 2 diabetes. AZ is building a metabolic and cardiovascular ...
The FDA also issued a new PMR for an additional confirmatory study to support full approval that will be completed no later than February 2028. About Vectibix® (panitumumab)Vectibix is the first and only human monoclonal an...