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Jazz Pharma to Fight FDA in Court Over Rival Sleep Drug Approval
Bloomberg Law· 3 days agoA pharmaceutical manufacturer known for its sleep medicines will argue Friday before a federal district court that the FDA violated an orphan drug ...
FDA fast track status granted to iECURE neonatal OTC deficiency treatment
Pharmaceutical Technology via Yahoo Finance· 4 days agoThe US Food and Drug Administration (FDA) has granted fast track designation for iECURE’s gene...
Regenex Bio eyes FDA meeting to confirm pivotal DMD trial
Clinical Trials Arena via Yahoo Finance· 3 days agoRGX-202 has received orphan drug, rare pediatric disease, and fast track designations from the FDA....
SN Bioscience Receives FDA Fast Track Designation for Small Cell Lung Cancer
Fort Wayne Journal Gazette· 2 days agoSN Bioscience Co. Ltd. (CEO Park Young-hwan) announced on May 7 that the FDA has granted Fast Track...
Avidity Biosciences Receives FDA Breakthrough Therapy Designation for Delpacibart Etedesiran (AOC...
FOX40 Sacramento· 4 days agoFood and Drug Administration (FDA) has granted Breakthrough Therapy designation to delpacibart etedesiran (AOC 1001), the company's lead clinical development ...
Biotech CEL-SCI gets FDA go-ahead to conduct investigational cancer immunotherapy study - Maryland...
The Daily Record· 4 days agoThe project will study the drug’s effectiveness in newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement, determined via PET scan, ...
Prediction: These 2 Growth Stocks Could Triple By 2030
Motley Fool via Yahoo Finance· 1 day agoAXS-12 is currently undergoing a phase 3 study. It has earned the orphan drug designation from the...
Shionogi secures licence for Maze’s Pompe disease treatment
Pharmaceutical Technology via Yahoo Finance· 2 days agoMaze will receive milestone payments contingent on the progress of the development, regulatory ...
Earnings call: Aquestive Therapeutics highlights progress and outlook for 2024
Investing.com· 3 days agoThe company also raised over $75 million in new capital and saw an 8% increase in total revenues,...
Mirum Pharmaceuticals Inc (MIRM) Q1 2024 Earnings Call Transcript Highlights: Soaring Sales and ...
GuruFocus.com via Yahoo Finance· 3 days agoQ: Can you provide any updates on the potential for orphan drug status for Maralixibat in the EU? A: (Christopher Peetz, CEO) - Discussions...particularly ...