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FDA advisers to weigh first psychedelic therapy in early June
FierceBiotech· 56 minutes agoLykos Therapeutics’ MDMA-assisted therapy is charting yet another first in the psychedelic field: an...
FDA approves Geneoscopy’s ColoSense test for CRC screening
Medical Device Network via Yahoo Finance· 6 hours agoLast year, the company signed a multi-year agreement with Labcorp for the distribution of the...
Eli Lilly Alzheimer’s drug gets FDA panel date after approval delay
The Hill· 16 minutes agoAn outside panel of advisers to the Food and Drug Administration (FDA) will meet next month to...
FDA Approves Azurity Pharmaceuticals’ Myhibbin as an Oral Suspension for Organ Transplant Recipients
Pharmaceutical Executive Magazine· 23 hours agoAxurity Pharmaceuticals announced that the FDA has officially approved Myhibbin as a ready-to-use...
Earnings call: Esperion reveals robust Q1 growth, FDA approval boosts
Investing.com· 11 hours agoThe company's U.S. net revenue saw a 46% increase compared to the previous year, amounting to $24.8...
FDA Sets June 10 Advisory Panel Meeting on Eli Lilly Alzheimer's Drug
Market Watch· 1 hour agoFood and Drug Administration has set June 10 as the date for its advisory committee meeting on the drugmaker's proposed Alzheimer's disease drug donanemab. An FDA decision ...
FDA panel to consider MDMA for PTSD treatment
NBC NEWS· 39 minutes agoThis would be the first FDA panel of outside experts to review a potential new PTSD treatment in 25 years. PTSD is a disorder caused by very stressful...
US FDA panel to discuss Eli Lilly Alzheimer's drug on June 10
Reuters· 2 hours ago, opens new tab said on Tuesday a panel of independent U.S. FDA advisers will discuss whether the...
Vertex files FDA approval ask for next-gen cystic fibrosis candidate, resumes diabetes cell therapy...
FierceBiotech· 5 hours agoVertex completed the regulatory submission a month before its goal of mid-2024, CEO Reshma Kewalramani, M.D., said on a first-quarter earnings call May 6. The investigational treatment is a ...
Geneoscopy Nabs FDA Approval for Stool-Based Colorectal Cancer Screening Test
GenomeWeb News· 3 hours agoOncology diagnostics firm Geneoscopy said Tuesday that the US Food and Drug Administration has approved its noninvasive, stool-based colorectal cancer screening test, ColoSense ...