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FDA Sets “Trial-Free” Precedent for Ultra-Rare Disease • BioNTech Founders Pivot • Hims Lands Ozempic

Mar 11, 2026

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9 min read

FDA Sets “Trial-Free” Precedent for Ultra-Rare Disease • BioNTech Founders Pivot • Hims Lands Ozempic

Leucovorin approved using literature evidence alone as BioNTech shares drop and GLP-1 telehealth tensions ease.

BioMed Nexus
BioMed Nexus

THE LATEST


Mar 10, 2026

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8 min read

Japan Approves First iPS Therapies • Xenon’s Record Epilepsy Data • FDA Eases Biosimilar Path

Azetukalner posts the strongest pivotal epilepsy efficacy ever as Vertex advances its kidney disease filing.

Mar 9, 2026

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11 min read

Servier Buys Day One for $2.5B • CBER Chief Prasad to Exit • Lonza’s $3B CDMO Pivot

MDA conference opens as MiniMed’s weak IPO and Zealand’s petrelintide data reshape the obesity race.

Mar 6, 2026

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9 min read

J&J’s 55-Day FDA Approval • CVS & Google Launch AI Health Platform • TrumpRx Stalls

Tec-Dara combo sets a new myeloma benchmark as Atavistik closes a $160M raise.

TRENDING


Prime Tests Two-Patient FDA Approval • Moderna’s $2.25B Patent Deal • Glenmark Flovent Win

Prime Tests Two-Patient FDA Approval • Moderna’s $2.25B Patent Deal • Glenmark Flovent Win

Ultra-rare regulatory precedent meets a record LNP settlement as generics pressure hits respiratory.

Teva Lands $400M Blackstone Deal • J&J's Fifth Fast Track • UCB's $1.1B CD19 Bet

Teva Lands $400M Blackstone Deal • J&J's Fifth Fast Track • UCB's $1.1B CD19 Bet

Non-dilutive capital structures dominate as TL1A race heats up.

FDA Splits Gene Therapy: uniQure Rejected, Intellia Hold Lifted

FDA Splits Gene Therapy: uniQure Rejected, Intellia Hold Lifted

Sham-controlled Phase 3 required for AMT-130 • Roche BTK Phase 3 win • ITC probes China biotech.

Week in Review: YUVIWEL Approved | Generate's Rough Debut | 44-Day Precedent

Week in Review: YUVIWEL Approved | Generate's Rough Debut | 44-Day Precedent

Ascendis wins achondroplasia approval with PRV, Generate IPO falls 21%, Key March PDUFAs.

FDA's 44-Day Approval | Sarepta CEO Exits | BioMarin Pulls Roctavian

FDA's 44-Day Approval | Sarepta CEO Exits | BioMarin Pulls Roctavian

Zongertinib sets a new regulatory speed record, Generate prices $400M IPO, Gene therapy reality check.

GSK’s $950M PAH Bet: 35Pharma Deal Signals Activin Race

GSK’s $950M PAH Bet: 35Pharma Deal Signals Activin Race

HS235 clinical push vs Winrevair heats up, MacroGenics lorigerlimab pause, Medtronic MiniMed IPO momentum

Novo Cuts GLP-1 Prices 50% Ahead of Federal Pricing Push

Novo Cuts GLP-1 Prices 50% Ahead of Federal Pricing Push

CagriSema miss reshapes obesity race • BREAKWATER doubles OS • MiniMed IPO roadshow

Gilead Pays 79% Premium for Arcellx | FDA Drafts Plausible Mechanism Pathway | Vir $1.7B Deal

Gilead Pays 79% Premium for Arcellx | FDA Drafts Plausible Mechanism Pathway | Vir $1.7B Deal

CAR-T scarcity trade ignites, Ultra-rare approvals reshaped, ASCO GU positioning begins

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