Iovance Biotherapeutics Completes Biologics License Application (BLA) Submission for…
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Browsing Tag
BLA
Junshi Biosciences and Coherus Share Update on the FDA Review of the Biologics…
- FDA has been unable to travel to China to conduct the required site inspection resulting in delayed action on the BLA - - Junshi Biosciences and Coherus are actively engaged in ongoing…
CytoDyn Announces Voluntary Withdrawal of BLA for HIV-MDR Due to CRO Data Management…
Company to complete and submit responses to FDA clinical hold Continues to study leronlimab in other HIV-related, NASH, and oncology indications Webcast to be held Monday, October 31,…
Mesoblast Submits New Information to FDA IND File in Response to Items in the CRL to…
NEW YORK, Oct. 02, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that it has…
Zai Lab Announces Acceptance by China’s NMPA of the BLA for Efgartigimod for Patients…
SHANGHAI and SAN FRANCISCO and CAMBRIDGE, Mass., July 13, 2022 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global…
Junshi Biosciences and Coherus Receive Complete Response Letter from U.S. FDA for…
– The CRL requests a quality process change Junshi Biosciences and Coherus believe is readily addressable – – BLA resubmission anticipated by mid-summer 2022 with expected six month…
MediWound Announces Additional $9 Million in Funding from BARDA to Support NexoBrid…
YAVNE, Israel, Feb. 10, 2022 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue…
CytoDyn Announces FDA Accepts Revised Rolling Review Timeline for Resubmission of its…
Management expects the non-clinical and CMC sections of the BLA to be resubmitted to FDA in November VANCOUVER, Washington, Oct. 27, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY)…
CytoDyn Names Chris Recknor, M.D. Senior Executive VP of Clinical Operations to…
New hires in Bioanalytical Sciences, Biostatistics, Clinical Regulatory, and Clinical Project Management will join the team of Drs. Srinivasan, Recknor, Ray, and Kelly to lead all clinical…
CytoDyn Submits Dose Justification Report to FDA to Begin Overcoming Deficiencies in…
Management works to advance its BLA filing seeking FDA approval for leronlimab as a combination therapy for HIV patients while continuing its evaluation of other potential indications…