News

Candel Therapeutics, Inc. (CADL)’s CAN-2409 Advances with FDA RMAT Status for Localized Prostate Cancer
Candel Therapeutics, Inc. (NASDAQ:CADL) has secured FDA Regenerative Medicine Advanced Therapy (RMAT) designation for its ...
The Pharma Letter15h
Daiichi and Merck pull patritumab deruxtecan BLA
Japan’s Daiichi Sankyo (TYO: 4568) and partner Merck & Co (NYSE: MRK) today revealed that the Biologics License Application ...
Pharmabiz1h
Daiichi Sankyo & Merck voluntarily withdraws patritumab deruxtecan BLA to treat locally advanced or metastatic EGFR-mutated NSCLC from US FDA
Daiichi Sankyo & Merck voluntarily withdraws patritumab deruxtecan BLA to treat locally advanced or metastatic EGFR-mutated NSCLC from US FDA: Basking Ridge, New Jersey Friday, Ma ...
Pharmaceutical Technology on MSN2d
FDA to review Otsuka’s sibeprenlimab application for IgAN
The US FDA has accepted for review Otsuka Pharmaceutical’s biologics licence application (BLA) for the monoclonal antibody, ...
The Pharma Letter1d
FDA refuses to file Savara BLA for Molbreevi
Texas, USA-based clinical-stage biopharma Savara (Nasdaq: SVRA) on Tuesday announced that the company received a refuse to ...
Moderna, Inc. (MRNA) Withdraws Application for COVID-flu Combination Vaccine
Moderna, Inc. (NASDAQ:MRNA) today announced that it had voluntarily withdrawn the pending Biologics License Application (BLA) ...
Merck, Daiichi Sankyo pull marketing application for lung cancer therapy
Merck (NYSE:MRK) and Daiichi Sankyo (OTCPK:DSNKY) (OTCPK:DSKYF) announced Thursday the voluntary withdrawal of their U.S.
Savara to meet FDA as marketing application is found to be incomplete
Savara (NASDAQ:SVRA) announced Tuesday its plans to meet with the U.S. FDA after the regulator issued a refusal to file (RTF) ...
Business Wire28d
Genmab to Submit Supplemental Biologics License Application (sBLA) to U.S. Food and Drug Administration for Epcoritamab Plus Rituximab and Lenalidomide (R2) in Patients with ...
Decision to submit based on a positive overall response rate (ORR) (p-value < 0.0001), one of the dual primary endpoints in the Phase 3 EPCORE ® FL-1 trial Full results from the trial will be ...