Atossa Therapeutics has received Rare Pediatric Disease (RPD) designation from the U.S. Food and Drug Administration for (Z)-Endoxifen in Duchenne muscular dystrophy (DMD), a strategic shift that positions the estrogen receptor modulator for possible use in pediatric neuromuscular disorders. If approved, the program could qualify for a transferable Priority Review Voucher, but the timeline and
KVP International has announced the acquisition of SafePath Laboratories and IVD Research, a diagnostics manufacturer and contract development and manufacturing organization (CDMO) provider headquartered in Carlsbad, California. With this move, KVP International aims to strengthen its footprint in veterinary diagnostics while unlocking the potential to expand into human health markets. This acquisition provides KVP International
FDA clears Prilenia’s PREVAiLS ALS trial. Can pridopidine validate neuroprotection and shift the treatment paradigm? Read the full analysis here.
TECVAYLI and DARZALEX FASPRO show major survival benefits in second-line multiple myeloma. Find out what the MajesTEC-3 trial means for clinical practice.