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 With the FDA’s latest draft guidance, it’s coming to fruition.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 ...
With companies including AstraZeneca, Pfizer and Revolution Medicines clamoring to get in on Summit Therapeutics’ ...
If approved, BridgeBio Pharma’s BBP-418—which, according to one Jefferies analyst, boasts “pretty darn compelling” data—would ...
Saudi Arabia is building the regulatory framework, partnerships infrastructure and IP landscape needed to support a biotech ...
INOVIO delivers a new nonsurgical treatment option with a broad indication for adults living with RRP, a rare and ...
New fixed, single-room configuration is designed to make DeepOCT+NIRS Imaging and X1-FFR physiology readily available for ...
Exploratory research in mSystems finds broader small-bowel gene-expression changes in ISO than in methanogen overgrowth or ...
Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX:13) today announces that regulatory filings for ORPATHYS ® (savolitinib) in ...
SonicForce is an investigational coronary intravascular lithotripsy (IVL) system that uses acoustic pressure waves, similar ...
Strategic Combination Brings Highly Innovative Late-Stage D-Fi Franchise Targeting Rare Diseases, with Orphan Drug-Designated ...
Avenzo Therapeutics, Inc. (“Avenzo”), a clinical-stage biotechnology company developing next-generation oncology therapies, ...
Presentation to explore the potential of RNA-splicing payloads to drive broad anti-tumor effects through direct cell killing ...
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