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September 09, 2021
The orphan drug designation for TCR² Therapeutics’ Gavo-cel will facilitate research into a treatment for cholangiocarcinoma.
The Coalition for Epidemic Preparedness Innovations stated that developing the next generation of COVID-19 vaccines will only be possible if comparator vaccines are available for clinical trials.
Moderna’s new single-dose vaccine will be a booster for both COVID-19 and the flu.
FDA placed a clinical hold on the BMN 307 Phearless Phase I/II study, which was evaluating an investigational PAH gene therapy in adults with PKU.
Impel Neuropharma’s Trudhesa, a nasal spray, received FDA approval for treating migraines in adults with and without aura.
September 07, 2021
Orphan drug designation for Polaryx’s PLX-200 will facilitate research into its use treating Krabbe Disease, a rare lysosomal genetic disorder.
September 02, 2021
FDA clearance of trans sodium crocetinate allows Diffusion to proceed with their latest Phase II oxygenation trial.
Immutep was granted a Chinese patent for LAG525, a LAG-3 antagonist antibody, under evaluation for cancer treatment.
September 01, 2021
SK and GSK announce the initiation of a Phase III clinical study of SK’s COVID-19 vaccine candidate, GBP510, in combination with GSK’s pandemic adjuvant.
Merck and Ridgeback Biotherapeutics announced the initiation of the Phase III clinical trial to evaluate an investigational oral antiviral therapeutic for the prevention of COVID-19 infection.