Providing FDA updates in the biotechnology space.
AVA6000 Receives Orphan Drug Designation from the FDA
AVA6000 is a form of the generic chemotherapy doxorubicin that has been modified using the pre|CISION technology so that it is activated predominantly in the tumour with the aim of sparing healthy tissue from exposure and improving the safety, tolerability and efficacy of the drug.
FDA Approves Konvomep ™ (omeprazole and sodium bicarbonate for oral suspension)
It is expected that Konvomep™ will become commercially available in pharmacies nationwide in Q1 2023.
Immuneering Announces Submission of IND Application to the FDA for Phase 1/2a Trial of IMM-1-104 to Treat Advanced Solid Tumors with RAS Mutations
The IND application supports a Phase 1/2a clinical trial of IMM-1-104, an oral once daily small molecule in development for the treatment of advanced RAS mutant solid tumors.
Bayer’s KERENDIA® (finerenone) Receives Updated Label to Include Findings From Phase III FIGARO-DKD Cardiovascular Outcomes Study in Patients With Chronic Kidney Disease and Type...
KERENDIA provides dual cardiorenal risk reduction in adults with CKD associated with T2D.
FDA Grants Fast Track Designation for Longeveron’s Lomecel-B™ Product for Treatment of Hypoplastic Left Heart Syndrome (HLHS) in Infants
Lomecel-B ™ is for the treatment of Hypoplastic Left Heart Syndrome (HLHS), a rare and life-threatening congenital heart defect affecting approximately 1,000 infants per year.
Trethera Announces FDA Orphan Drug Designation Granted to TRE-515 for the Treatment of Demyelinating Optic Neuritis
TRE-515 is a first-in-class drug targeting the enzyme deoxycytidine kinase (dCK).