Seres Therapeutics Gets FDA Green Signal to Start SER-155 Human Trials
The FDA has signed off Seres Therapeutics Inc’s (NASDAQ:MCRB) Investigational New Drug (IND) application for SER-155 to initiate Phase 1 trial.…
BeyondSpring’s Plinabulin US Application for Chemo-Induced Neutropenia Under Review
The FDA has accepted for review BeyondSpring Inc’s (NASDAQ:BYSI) marketing application seeking approval for the use of plinabulin in combination with…
Akebia Therapeutics Stock Jumps as FDA Accepts Vadadustat US Application in CKD-Related Anemia
Akebia Therapeutics Inc (NASDAQ:AKBA) and its collaborator Otsuka Holdings (OTC:OTSKY) have announced that the FDA has accepted to review vadadustat’s marketing application for…
Sanofi Stops Venglustat Development In Rare Genetic Kidney Disorder
Sanofi SA (NASDAQ:SNY) has halted the clinical program of venglustat in autosomal dominant polycystic kidney disease (ADPKD). Although the safety profile…
Lannett Announces FDA Acceptance, As A Priority Original ANDA, Of The Generic Advair Diskus Filing
Lannett Company, Inc. (NYSE:LCI) today announced the U.S. Food and Drug Administration (FDA) has accepted the Abbreviated New Drug Application (ANDA) for Fluticasone Propionate and Salmeterol inhalation powder (100/50
The Week Ahead In Biotech: ASCO Presentations Front And Center, FDA Decisions Due For Scynexis, Liminal And Alkermes
After having declined through the first half of the week, biotech stocks staged a recovery to close higher in the trading week ended May 28. Broader market sentiment and company-specific news flow dictated stock moves during the week.
Pfizer and BioNTech Confirm First Authorization in European Union for COVID-19 Vaccine in Adolescents
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the Conditional Marketing Authorization (CMA) for COMIRNATY® in the European Union (EU) has been expanded to include individuals 12 to 15 years of age.
BridgeBio Pharma’s Affiliate QED Therapeutics And Partner Helsinn Group Announce FDA Approval Of TRUSELTIQ For Patients With Cholangiocarcinoma
Pivotal study demonstrated a clinically meaningful rate of tumor shrinkage (overall response rate) and duration of response in patients with previously-treated advanced cholangiocarcinoma (CCA) harboring an FGFR2 fusion