QuantalX Secures FDA Clearance for its breakthrough Delphi stimulator, advancing direct brain health diagnosis at the point of care
QuantalX Neuroscience Ltd. is proud to announce that its Delphi-MD (Direct Electrophysiological Imaging Device), an ...
Actuate Announces FDA Rare Pediatric Disease Designation Granted to Elraglusib for Treatment of Ewing Sarcoma
Ewing Sarcoma is a Highly Metastatic Form of Sarcoma and the Second Most Prevalent Primary Malignant Tumor in Children and ...
Actuate Therapeutics: FDA Grants Pediatric-Disease Status to Ewing Sarcoma Treatment
Actuate Therapeutics said its treatment for Ewing sarcoma was granted rare pediatric-disease designation from the Food and Drug Administration. Chief Executive Daniel Schmitt said early clinical data ...
Zevra Therapeutics Reports Third Quarter 2024 Financial Results And Corporate Updates
FDA approval of MIPLYFFATM and product launch cap third quarter filled with multiple commercial and clinical development milestones Zevra ...
US FDA declines full approval for Intercept's liver disease drug
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
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FDA commissioner suggests RFK Jr. and Trump might compromise an agency ‘at peak performance’
The agency’s ability to hire and retain skilled employees may be in jeopardy given Trump ally Robert F. Kennedy Jr.’s ...
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Continuous Glucose Monitors for All? Opinions Remain Mixed
The question is more urgent as over-the-counter continuous glucose monitoring devices become more widely available.
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AstraZeneca: New drug data, promising earnings and a $3.5B R&D investment
AstraZeneca’s earnings were boosted by its oncology, cardiovascular, respiratory and immunology (R&I), and rare disease ...
Kennedy’s F.D.A. Wish List: Raw Milk, Stem Cells, Heavy Metals
Robert F. Kennedy Jr., one of President-elect Donald J. Trump’s advisers on health, is taking aim at the agency’s oversight ...
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No-Moat BridgeBio's Valuation Driven by Pending Approval of Acoramidis; Positive Long-Term Outlook
The Food and Drug Administration has accepted BridgeBio’s new drug application ... company's ability to successfully bring its products to market and achieve its financial objectives. Product ...
Avadel Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2024 Financial Results
Generated $50.0 million in net revenue from sales of LUMRYZ™ ----2,300 patients on LUMRYZ as of September 30th, including 700 patients that ...
Perspective Therapeutics Provides Recent Business Highlights and Reports Fiscal 3Q 2024 Results
Advancing investigation of [212Pb]VMT01 as a monotherapy and in combination with the anti-PD-1 antibody, nivolumab, in patients with previously ...