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FDA fast track status granted to iECURE neonatal OTC deficiency treatment
Pharmaceutical Technology via Yahoo Finance· 5 days agoThe company can now hold frequent interactions with the FDA to discuss the development plan and...
SN Bioscience Receives FDA Fast Track Designation for Small Cell Lung Cancer
Fort Wayne Journal Gazette· 3 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· 5 days agoFood and Drug Administration (FDA) has granted Breakthrough Therapy designation to delpacibart etedesiran (AOC 1001), the company's lead clinical development ...
STEALTH BIOTHERAPEUTICS' BARTH SYNDROME NDA RECEIVES PRIORITY REVIEW DESIGNATION
WRBL Columbus· 6 days agoFood and Drug Administration ("FDA") has now determined that its New Drug Application ("NDA") for elamipretide for the treatment of Barth ...
Jaguar Health Announces Submission of Clinical Trial Applications for Crofelemer for the Rare...
San Mateo Daily Journal· 4 days agoJaguar's novel plant-based prescription drug crofelemer has been granted Orphan Drug Designation by the FDA and the European Medicines Agency for both MVID and SBS
Phanes Therapeutics, Inc. Announces Clinical Supply Agreement with Roche to Evaluate PT217 in...
Yucaipa News Mirror· 5 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
Shionogi secures licence for Maze’s Pompe disease treatment
Pharmaceutical Technology via Yahoo Finance· 3 days agoIts potential extends to both a standalone treatment and an adjunctive therapy alongside enzyme...
Syndax Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Clinical and...
WTNH-TV New Haven· 5 days agoSyndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an...
Zai Lab Announces Approval of AUGTYRO™ (repotrectinib) for Patients with ROS1-positive NSCLC by...
Benzinga· 10 hours agoThe approval is based on the pivotal TRIDENT-1 trial, in which AUGTYRO achieved a high response rate and durable responses, including robust intracranial responses Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688)) today
Small Business - The Andalusia Star-News | The Andalusia Star-News
The Andalusia Star-News· 3 days agoSoligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an ...