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FDA approves Priovant’s Lisraya for dermatomyositis

This is the first oral drug treatment for this rare disease in adults

- PMLiVE

AstraZenca’s Etcamah combination therapy given FDA Accelerated Approval for breast cancer

The approval was based on phase 3 trial results showing a 56% risk reduction in disease progression

- PMLiVE

Pfizer and BioNTech’s XFG-adapted COVID-19 vaccine approved by US FDA

The 2026-2027 vaccine targets the XFG variant to more closely match current variants

- PMLiVE

Pfizer and Valneva’s application for Lyme disease vaccine candidate validated by EMA

There are currently no approved human vaccines for Lyme disease

- PMLiVE

FDA grants Fast Track status for peanut allergy immunotherapy

The treatment uses peptides designed to retrain the immune system to tolerate peanuts

- PMLiVE

US FDA accepts supplemental Biologics License Application for Merck’s Enflonsia

The treatment is to protect children under two years of age from respiratory syncytial virus

- PMLiVE

Novartis’ Pluvicto approved by FDA for metastatic hormone-sensitive prostate cancer

More than 186,000 men are diagnosed each year with mHSPC globally

- PMLiVE

Pfizer announces phase 3 results for nonsegmental vitiligo treatment

Litfulo delivered significant, clinically meaningful improvements for both face and body

- PMLiVE

Pfizer’s Talzenna plus Xtandi gets FDA Priority Review for metastatic prostate cancer

The phase 3 trial showed greater than 50% improvement in radiographic progression-free survival

- PMLiVE

Bristol Myers Squibb’s New Drug Application for mezigdomide accepted by FDA

Mezigdomide improves progression-free survival in patients with relapsed or refractory multiple myeloma

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Teva submits FDA application for paediatric Tourette syndrome therapy

Ecopipam could become the first new FDA-approved treatment for paediatric Tourette syndrome in over ten years

- PMLiVE

Roche’s Enspryng given FDA Priority Review as thyroid eye disease treatment

This is the first and only at-home subcutaneous treatment option for this disease

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