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AZN Gets CHMP Nod for Imfinzi in Muscle-Invasive Bladder Cancer
AstraZeneca AZN announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) rendered ...
BeiGene gets EU backing for neck and head cancer treatment
BeiGene (NASDAQ:ONC) (OTCPK:BEIGF) announced that an advisory committee of the European Medicines Agency (EMA), endorsed its ...
Healio1h
FDA grants rare pediatric disease designation for Stargardt disease gene therapy
The FDA granted rare pediatric disease designation for OCU410ST, a gene therapy designed to treat ABCA4-associated ...
Precision Medicine Online2h
EMA's CHMP Recommends Autolus' CAR T-Cell Therapy Aucatzyl for B-ALL
NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Autolus Therapeutics' autologous CD19-directed CAR T-cell therapy Aucatzyl ...
BeiGene's Tevimbra Gets Positive Opinion from Committee for Medicinal Products for Human Use
BeiGene's Tevimbra gets a highly sought after recommendation.
Ophthalmology Times4h
Ocugen’s OCU410ST receives Rare Pediatric Disease Designation for the treatment of ABCA4-associated retinopathies
OCU410ST has received Rare Pediatric Disease Designation for ABCA4-associated retinopathies, potentially allowing Ocugen to ...
Medscape4d
Blenrep Gets European Nod to Treat Multiple Myeloma
Adding Blenrep to standard therapy prolonged progression-free survival in patients with relapsed or refractory multiple ...
Ocugen's Retina Gene Therapy Drug Gets Rare Disease Designation From FDA
Ocugen's drug to treat retina diseases received a rare pediatric disease designation from U.S. regulators. The biotechnology said Tuesday that the Food and Drug Administration granted the designation ...