BioSpace

Plug-and-play gene therapy: FDA executes on vision that’s been in the works for years

Former biologics boss Peter Marks had a vision. With the FDA’s latest draft guidance, it’s coming to fruition. Speaking with BioSpace, current CBER leader Karim Mikhail said the “adapted pathway” is ...
BioSpace

Drugmakers rush to pair up with Summit’s ivonescimab ahead of key verdict

With companies including AstraZeneca, Pfizer and Revolution Medicines clamoring to get in on Summit Therapeutics’ ...
BioSpace

Philips launches HyperVue Integrated System in the U.S., bringing advanced coronary imaging and physiology into the cathlab

New fixed, single-room configuration is designed to make DeepOCT+NIRS Imaging and X1-FFR physiology readily available for ...
BioSpace

INOVIO Announces FDA Accelerated Approval of VOCERYQ™, an Immunotherapy to Reduce the Frequency of Surgery in Adults with Recurrent Respiratory Papillomatosi…

INOVIO delivers a new nonsurgical treatment option with a broad indication for adults living with RRP, a rare and ...
BioSpace

BridgeBio gears up for rare muscular dystrophy launch with FDA approval in sight

If approved, BridgeBio Pharma’s BBP-418—which, according to one Jefferies analyst, boasts “pretty darn compelling” data—would ...
BioSpace

Can Saudi Arabia’s burgeoning biotech hub withstand geopolitical pressures?

Saudi Arabia is building the regulatory framework, partnerships infrastructure and IP landscape needed to support a biotech ...