OR WAIT null SECS
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.
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
The Novel Excipient Review Pilot Program will allow excipient manufacturers to obtain FDA review of certain novel excipients prior to use in drug formulations.
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
Will FDA’s approval of Semglee create a surge in the development of interchangeable biosimilars?
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.
The European Commission has granted marketing authorization to Incyte and MorphoSys for Minjuvi (tafasitamab) in combination therapy with lenalidomide to treat relapsed or refractory DLBCL.