Food and Drug Administration (FDA)
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The FDA has issued special designations that could improve the lives of millions with recurrent glioblastoma or hemophilia diagnoses.
The U.S. FDA has requested some additional data from BioMarin Pharmaceuticals for the BLA it filed for the hemophilia A therapy valoctocogene roxaparvovec.
Portland-based Children’s Cancer Therapy Development Institute is discovering more targeted drugs for childhood cancers and driving them into clinical development with industry partner Artisan Biopharma.
The FDA has decided to extend the Prescription Drug User Fee Act (PDUFA) review date for TG Therapeutics’s ublituximab until December 2022.
RhoVac AB announced Tuesday that its candidate therapeutic for prostate cancer failed to meet targets in a Phase IIb study.
GSK announced that it is acquiring Affinivax for up to $3.3 billion to gain its novel class of developmental vaccines and its MAPS technology.
The long weekend saw BMS’s Opdivo, Novartis’s Kymriah and Roche’s Evrysdi win FDA approvals in new indications.
TikoMed’s contribution to the fight is ILB, a novel patented formulation of a modified glycosaminoglycan that works to tackle ALS through neurotrophic and myogenic effects.
A roundup of last week’s top clinical trial announcements and news, including updates from Pfizer, BioNTech, Ocugen and more.
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