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FDA fast track status granted to iECURE neonatal OTC deficiency treatment
Pharmaceutical Technology via Yahoo Finance· 4 days agoThe therapeutic benefits of ECUR-506 have been recognised previously, with the FDA awarding it rare...
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 ...
Prediction: These 2 Growth Stocks Could Triple By 2030
Motley Fool via Yahoo Finance· 16 hours agoConsider, for instance, AXS-12, a potential treatment for cataplexy (sudden muscular weakness) in...
STEALTH BIOTHERAPEUTICS' BARTH SYNDROME NDA RECEIVES PRIORITY REVIEW DESIGNATION
WRBL Columbus· 5 days agoFood and Drug Administration ("FDA") has now determined that its New Drug Application ("NDA") for elamipretide for the treatment of Barth syndrome is entitled to a Priority Review designation ...
Phanes Therapeutics, Inc. Announces Clinical Supply Agreement with Roche to Evaluate PT217 in...
The Record Gazette· 3 days agoPT217 is Phanes' first-in-class bispecific antibody targeting DLL3 and CD47; atezolizumab (TECENTRIQ®) is Roche's anti-PD-L1 monoclonal antibodyThe clinical supply agreement will focus on evaluating PT217 in combination with atezolizumab for
Lisata Therapeutics reports strong 1Q performance, cash to support operations into 2026
Proactive Investors· 3 days agoCEO David Mazzo told shareholders that the company is off to a strong start to 2024, with Phase 2b...
Shionogi secures licence for Maze’s Pompe disease treatment
Pharmaceutical Technology via Yahoo Finance· 2 days agoIts potential extends to both a standalone treatment and an adjunctive therapy alongside enzyme...
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 program, for ...
Jaguar Health Announces Submission of Clinical Trial Applications for Crofelemer for the Rare...
Digital Journal· 3 days agoJaguar's novel plant-based prescription drug crofelemer has been granted Orphan Drug Designation by the FDA and the European Medicines ...
Regeneron gene therapy improves hearing in two children
BioPharma Dive via Yahoo Finance· 4 days agoLike Lilly’s experimental treatment, Regeneron’s medicine uses a specially engineered virus to...