Why Novavax Shares Are Plunging Today Despite Much Awaited FDA Emergency Nod?
The European Medicines Agency identified severe allergic reactions as potential side effects of Novavax Inc’s (NASDAQ:NVAX) COVID-19 vaccine. A few cases of…
Summit Therapeutics Mulls Additional Trial For Its Once Failed Infection Candidate
Summit Therapeutics Inc (NASDAQ:SMMT) provided an update on the clinical development of ridinilazole, its lead Phase 3 product candidate for Clostridioides…
U.S. FDA Defers Decision On BeiGene’s Filing For Esophageal Carcinoma Due To Pending Inspection
The U.S. Food and Drug Administration (FDA) has deferred decision on the Biologics License Application (BLA) for BeiGene’s (NASDAQ: BGNE) tislelizumab as a second-line treatment for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC).
Clene’s CNM-Au8 Shows Decreased Mortality Amyotrophic Lateral Sclerosis Patients
Clene Inc (NASDAQ:CLNN) reported significantly improved survival in Amyotrophic lateral sclerosis (ALS) patients initially treated with CNM-Au8 compared to initially randomized…
Lantern Pharma Gets FDA Clearance for Mid-Stage Lung Cancer Study
The Food and Drug Administration (FDA) has announced clearance to Lantern Pharma (NASDAQ: LTRN) to proceed with Phase 2 clinical trial of its investigational new drug LP-300 in combination with chemotherapy for never smoker patients with advanced non-small cell lung cancer (N
Pasithea Therapeutics Awarded $694K Drug Development Research Grant
-- AUD $1 million (U.S $694,000) grant transferred as part of Alpha-5 Integrin, LLC transaction --
-- Provides approximately U.S. $694,000 of non-dilutive funding --
MIAMI BEACH, Fla., July 14, 2022 (GLOBE NEWSWIRE) --
Amryt Receives Orphan Drug Designation From The FDA For Mycapssa For The Treatment Of Carcinoid Syndrome
Amryt (NASDAQ:AMYT), a global, commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing novel treatments for rare diseases, is pleased to announce that the US Food and Drug
Lantern Pharma Receives FDA Authorization To Initiate Its Phase 2 Clinical Trial, Harmonic, For LP-300 In Never Smokers With Non-Small Cell Lung Cancer
The Harmonic™ trial is a Phase 2 multi-center study focused on never smokers with advanced non-small cell lung cancer (NSCLC) and will begin patient enrollment during Q3 2022.
In a previous Phase 3
Regeneron-Sanofi’s Dupixent Hits Primary Goal In Esophagitis Patients Below 11 Years
Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi SA’s (NASDAQ:SNY) Phase 3 trial of Dupixent (dupilumab) in children aged 1 to 11 years…
BeiGene Provides Regulatory Update On The U.S. Biologics License Application For PD-1 Inhibitor Tislelizumab In 2L ESCC
FDA Defers Action on BLA Until Required Inspections Can Be Completed
Due to COVID Travel Restrictions, Inspections Could Not Be Completed During Review Period