One combined protocol can de-risk FDA acceptance of foreign data, capture the U.S. safety and PK evidence regulators want, ...
FDA’s accelerated approval of GSK’s Jemperli gives some patients with locally advanced rectal cancer a treatment that could ...
China’s out-licensing is moving beyond me-too and me-better therapies, with a growing share of deals centering on assets in the running to be first ...
The Roche-Hansoh collaboration announced Monday is part of the Chinese pharma’s strategy to move beyond asset licensing to co ...
• China regulation and export risk — Order 818 has sharply narrowed the IIT pathway and a proposed export-control regime ...
An emerging blood biomarker raises a question worth drug developers’ attention: are conventional measures of disease burden ...
For pure gene silencing, siRNA offers better durability, deeper knockdown and cleaner safety, while ASOs still matter ...
Rumors are circulating that prominent preclinical AI drug discovery biotech Isomorphic Labs is in negotiations to raise new ...
The announcement of FDA’s rare disease framework initiative marks the start of an effort patient advocates and orphan drug ...
For pure gene silencing, siRNA offers better durability, deeper knockdown and cleaner safety, while ASOs still matter ...
Arrowhead’s first tau-lowering data in humans bring brain shuttles a step closer to opening the CNS to systemically ...
China is emerging as a hub for RNAi therapies, drawing Western pharmas into a wave of deals for the modality over the past ...