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FDA accepts Beigene’s first filing outside China; BLA seeks nod for anti-PD-1 tislelizumab

Sep. 21, 2021

The FDA has accepted for review Novartis AG and Beigene Ltd.’s BLA filing for the anti-PD-1 monoclonal antibody tislelizumab.

BioWorld Asia Regulatory Cancer China BLA FDA

Today's news in brief

BioWorld

BioWorld briefs for Dec. 16, 2025.

Today's news in brief

BioWorld MedTech

BioWorld MedTech briefs for Dec. 16, 2025.

Businesspeople shaking hands, meeting with cityscape, charts

Deals and an M&A strengthen end-of-year numbers

BioWorld

Two large deals and an acquisition, totaling about $4.64 billion in all, are helping wrap up what’s turning out to be a strong year. Through the first 11 months...

Illustration of tau accumulating in a neuron cell.

ADEL wins $1.04B Sanofi deal for tau-targeting Alzheimer’s drug

BioWorld

ADEL Inc. closed a year-end licensing deal worth up to $1.04 billion with Sanofi SA for ADEL-Y01, a specific tau-targeting Alzheimer’s disease drug candidate in a...

Neutrophils put the brakes on fat loss

BioWorld Science

Fat tissue balances energy by storing lipids during times of abundance and mobilizing them when needed, yet sustained metabolic stress demands mechanisms that...