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tropical diseases

- PMLiVE

Sanofi/Regeneron’s Dupixent gets US label update for atopic dermatitis

Dupixent’s label now includes data supporting its use in hand and foot atopic dermatitis

- PMLiVE

FDA approves Vertex/CRISPR’s Casgevy gene therapy for beta thalassaemia

The companies estimate that approximately 1,000 patients in the US will be eligible for the one-time treatment

- PMLiVE

Merck granted FDA approval for Keytruda combination in cervical cancer

The decision marks the third FDA-approved indication for Keytruda in cervical cancer

- PMLiVE

FDA authorises Florida’s request to import cheaper prescription drugs from Canada

The first-of-its-kind importation programme is expected to save the state up to $180m in its first year

- PMLiVE

AstraZeneca and Ionis’ Wainua granted FDA approval for rare disease ATTRv-PN

ATTRv-PN leads to peripheral nerve damage with motor disability within five years of diagnosis

- PMLiVE

FDA establishes advisory committee for genetic metabolic disease treatments

The committee will evaluate the potential benefits and risks of new therapies for diagnosis, prevention and treatment

- PMLiVE

FDA grants fast track designation to Candel’s immunotherapy in pancreatic cancer

The disease is the fourth leading cause of cancer-related death in the US, accounting for 3.3% of new cancer cases

- PMLiVE

FDA approves two cell-based gene therapies for sickle cell disease

Vertex/CRISPR and bluebird bio’s gene therapies have been approved to treat patients aged 12 years and older

- PMLiVE

Novartis’ Fabhalta approved by FDA as first oral monotherapy for rare blood disease PNH

The rare blood disease is estimated to affect only ten to 20 people per million worldwide

- PMLiVE

Eli Lilly’s Jaypirca granted FDA accelerated approval for non-Hodgkin lymphomas

Approximately 18,740 new cases of CLL have been diagnosed in the US this year

- PMLiVE

FDA to investigate risk of T-cell malignancy from CAR-T cell immunotherapies

The regulator will monitor approved BCMA- or CD19-directed autologous CAR-T cell immunotherapies

- PMLiVE

FDA approves SpringWork’s Ogsiveo as first therapy for desmoid tumours

Approximately 1,650 people in the US are diagnosed with the rare non-cancerous tumours each year

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