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BioCentury
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BioCentury | Oct 16, 2024
Data Byte

Trio of indications for Bimzelx among FDA’s September label expansions 

Agency converts accelerated approvals of Filspari and Retevmo to full
BioCentury | Jul 23, 2024
Data Byte

Accelerated approvals of Epkinly, Augtyro, Krazati among FDA’s June label expansions

The month also brought conversions to full approval for Retevmo and Sirturo
BioCentury | Jun 18, 2024
Data Byte

FDA label expansions in May: Two new indications for BMS’s CAR T

Plus: Lilly’s RET inhibitor receives accelerated approval for younger patients
BioCentury | Jan 27, 2024
Data Byte

EMA’s CHMP confirms non-renewal of Translarna, denies new medicines Nezglyal and Syfovre

On the positive side of the ledger, BMS’s CAR T therapy Abecma headed for a line extension
BioCentury | Nov 3, 2023
Product Development

Innovating oncology evidence generation through new endpoints

Eli Lilly is among the companies pioneering alternative oncology endpoints to capture make-or-break nuances in data
BioCentury | Oct 24, 2023
Product Development

Lilly aims to change the conversation around precision oncology

With Phase III data at ESMO, Lilly hopes to make Retevmo a case study for success in precision oncology
BioCentury | Aug 25, 2023
Finance

Aug. 24 Quick Takes: Ferring banks $300M up front in Royalty Pharma deal

Plus: Aprinoia, SPAC terminate merger agreement and Exelixis’ cabozantinib shows PFS benefit in NETs and updates on the IRA, RSV and more 
BioCentury | Aug 10, 2023
Finance

Aug. 9 Quick Takes: Alltrna raises $109M for unified approach to stop codon diseases

Plus: Venture cash for ADARx, Georgiamune, Neurophth and updates from Regeneron-Decibel, Novartis, Sunbird-Glympse, Denali-Takeda and more
BioCentury | Aug 9, 2023
Product Development

Amid leadership shift, Mirati plots label expansions

Mirati raises $300M follow-on following CEO change and signs of promising sales growth trajectory for KRAS inhibitor
BioCentury | Aug 5, 2023
Regulation

Aug. 4 Quick Takes: Sage-Biogen get FDA approval for one of two depression indications

Plus: Galapagos trims Jyseleca guidance, seeks options; and updates from Mesoblast, Lilly, Sino and more
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