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Brief

Structured intelligence notes on clinical, regulatory, and commercial events in biotech and pharma.
17
Apr
FDA sets PDUFA date for Telix’s TLX101-Px glioma imaging

FDA sets PDUFA date for Telix’s TLX101-Px glioma imaging

September 2026 PDUFA date given to Telix’s glioma imaging agent.
1 min read
16
Apr
NICE positions semaglutide in cardiovascular prevention

NICE positions semaglutide in cardiovascular prevention

Guidance expands semaglutide use beyond weight management into cardiovascular prevention.
1 min read
15
Apr
Filspari wins first FDA nod for FSGS Proteinuria

Filspari wins first FDA nod for FSGS Proteinuria

Sparsentan cut proteinuria 46% versus 30% for irbesartan at 108 weeks in Phase III DUPLEX, the largest FSGS trial to date, but missed its primary kidney function endpoint.
2 min read
14
Apr
Nxera hits second Lilly milestone in metabolic deal

Nxera hits second Lilly milestone in metabolic deal

Nxera's NxWave platform has now delivered two development milestones to Lilly within ten months, signaling recurring delivery
1 min read
13
Apr
AtaiBeckley's BPL-003 shows rapid, durable TRD response on SSRIs

AtaiBeckley's BPL-003 shows rapid, durable TRD response on SSRIs

Single intranasal dose of BPL-003 achieved 66.7% antidepressant response by Day 2 in treatment-resistant depression patients on stable SSRIs, with 83% durability at Day 85.
3 min read