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BioCentury
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BioCentury | Feb 5, 2025
Product Development

Biotechs make inroads to precision medicine, solving long-standing problems

70% of new precision medicines approved by FDA in past three years were not sponsored by major pharmas
BioCentury | Sep 18, 2024
Product Development

View from ESMO: iTeos data keep TIGIT alive, for now

Plus readouts from Genmab, AstraZeneca, Merck, Astellas and more
BioCentury | Sep 14, 2024
Product Development

Rybrevant shows colorectal cancer promise in latest bispecifics win

J&J to bring Rybrevant into two Phase III colorectal cancer studies based on Phase II data
BioCentury | Jul 27, 2024
Data Byte

Junshi’s PD-1 among seven new products recommended by EMA’s CHMP

Plus: Astellas’ Vyloy on track to become EU’s first CLDN18.2 therapy, and 11 products likely headed for label expansions
BioCentury | Jun 27, 2024
Product Development

Solving for the medical and business case in pediatric cancer — Day One

CEO Jeremy Bender on building a strategy for pediatric cancer therapies that serves both patients and investors 
BioCentury | May 2, 2024
Data Byte

FDA approved five NMEs in April

Day One, X4 and ImmunityBio each received their first drug approvals 
BioCentury | Apr 25, 2024
Regulation

FDA’s Ojemda approval marks Day One’s transition to commercial company

No black box warning and a broad label for the pediatric brain cancer therapy
BioCentury | Mar 8, 2024
Product Development

Pfizer blends modality tools in new vision for oncology unit

Pharma outlines goals for oncology business as it moves to integrate ADC play Seagen 
BioCentury | Feb 17, 2024
Regulation

With eyes on manufacturing, Iovance’s TIL therapy reaches long-awaited, world-first approval 

Therapy will be made at the biotech’s Philadelphia facility and a nearby CDMO, with plans to serve ‘up to several thousand patients annually’
BioCentury | Oct 30, 2023
Regulation

As priority review starts, Day One preps for shift to commercial phase

Five-year-old biotech receives April PDUFA date for pan-RAF inhibitor to treat slow-moving pediatric brain cancer
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