Nasdaq

CTI BioPharma Announces Completion of Rolling Submission of New Drug Application (NDA) for Pacritinib in Myelofibrosis Patients with Severe Thrombocytopenia

SEATTLE, March 31, 2021 /PRNewswire/ -- CTI BioPharma Corp. (Nasdaq: CTIC) today announced that it has completed a rolling New Drug Application ("NDA") submission to the U.S. Food and Drug ...
Business Wire

Amylyx Pharmaceuticals Announces Plan to Submit New Drug Application (NDA) for AMX0035 for the Treatment of ALS in the Coming Months

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals, Inc. today announced its intention to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for AMX0035 (sodium ...
Nasdaq

Zosano Pharma Announces NDA Resubmission Plans Following Type A Meeting with FDA

FREMONT, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced that the company completed its Type A meeting ...
MarketWatch

BeyondSpring stock plunges after FDA says NDA for CIN treatment 'cannot be approved' in current form

Shares of BeyondSpring Inc. plunged 55.2% toward a record low in premarket trading Wednesday, after the biopharmaceutical company said that it has received a complete response letter (CRL) from the ...