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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.
A report from the bipartisan Congressional Budget Office analyzes how drug pricing policies could reduce the number of new therapies coming to market.
Will FDA’s approval of Semglee create a surge in the development of interchangeable biosimilars?
September 01, 2021
FDA will now require new and updated warnings about the increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions.
Two of FDA’s vaccine regulators will be leaving in the fall of 2021, which has the potential to impact COVID-19 vaccine recommendations for both children under the age of 12 and booster shots.
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.
August 31, 2021
FDA formally unveiled its plan for revising and renewing its fee program for drugs and biologics.
August 27, 2021
Japan has suspended the use of more than 1.63 million potentially contaminated doses of the Moderna vaccine.
FDA has cleared QSAM Biosciences’s IND application for Samarium-153 DOTMP (CycloSam).