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MFN Pricing Is Moving Fast – Here’s What Matters

With GENEROUS, GUARD, and GLOBE all released since December, 185 pages of policy will materially impact U.S. drug pricing — and yes, it's a lot to digest. In a new...

Genesis Research Group

- PMLiVE

Johnson & Johnson’s Darzalex Faspro regimen receives FDA approval for multiple myeloma

Multiple myeloma has an average five-year survival rate of 59.8% and is currently incurable

- PMLiVE

ISPOR’s 2026–2027 HEOR Trends report: The Era of Evidence Judgment

In response to ISPOR’s recently published 2026-2027 HEOR Trends, David Miller, CEO, Genesis Research Group, suggests that we’re no longer being evaluated on our ability to produce data, but on...

Genesis Research Group

- PMLiVE

Novartis’ ianalumab receives FDA Breakthrough Therapy designation for Sjögren’s disease

Approximately half of those with Sjögren’s disease are thought to be undiagnosed

- PMLiVE

FDA approves first gene therapy for Wiskott-Aldrich syndrome

Symptoms of the rare disease include bleeding, eczema and frequent infections

- PMLiVE

FDA launches TEMPO digital health pilot

Digital technologies can improve remote patient care for those with chronic diseases

- PMLiVE

Richard Pazdur, FDA’s drug evaluation chief, to leave FDA just weeks into new role

Pazdur was previously head of the FDA’s Oncology Center of Excellence

- PMLiVE

Merck KGaA given FDA Fast Track designation for generalised myasthenia gravis drug

Cladribine capsules could become the first ever oral treatment for gMG

- PMLiVE

Johnson & Jonson secures FDA approval for multiple myeloma treatment

Support for first and only high-risk smouldering multiple myeloma treatment came from positive phase 3 trial results

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